Food and Drug Administration: Difference between revisions
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== Circumcision Injury Reports == | == Circumcision Injury Reports == | ||
As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews | As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice about the [[Mogen]] and [[Gomco]] clamps after receiving about 20 injury reports a year since 1996, including lacerations, hemorrhaging, penile amputation and urethral damage.<ref>{{REFnews | ||
| last=Hennessy-Fiske | |last=Hennessy-Fiske | ||
| first=Molly | |first=Molly | ||
|url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |||
| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |title=Injuries linked to circumcision clamps | ||
| title=Injuries linked to circumcision clamps | |date=2011-09-26 | ||
| date=2011-09-26 | |publisher=Los Angeles Times | ||
| publisher=Los Angeles Times | |quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice... | ||
| quote=As far back as August 2000, the U.S. Food and Drug Administration issued a public health notice... | |accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews | ||
| accessdate=2011-09-25}}</ref> Instead of recalling the devices, the FDA advised users to make sure they were using the devices according to the manufacturer's specifications.<ref>{{REFnews | |last=Hennessy-Fiske | ||
| last=Hennessy-Fiske | |first=Molly | ||
| first=Molly | |url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | ||
|title=Injuries linked to circumcision clamps | |||
| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |date=2011-09-25 | ||
| title=Injuries linked to circumcision clamps | |publisher=Los Angeles Times | ||
| date=2011-09-25 | |quote=Instead of recalling the devices, the FDA advised users to make sure... | ||
| publisher=Los Angeles Times | |accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews | ||
| quote=Instead of recalling the devices, the FDA advised users to make sure... | |last=Hennessy-Fiske | ||
| accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews | |first=Molly | ||
| last=Hennessy-Fiske | |url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | ||
| first=Molly | |title=Injuries linked to circumcision clamps | ||
|date=2011-09-25 | |||
| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |publisher=Los Angeles Times | ||
| title=Injuries linked to circumcision clamps | |quote=The agency also cautioned against using replacement parts on the Gomco clamp... | ||
| date=2011-09-25 | |accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews | ||
| publisher=Los Angeles Times | |last=Hennessy-Fiske | ||
| quote=The agency also cautioned against using replacement parts on the Gomco clamp... | |first=Molly | ||
| accessdate=2011-09-25}}</ref> In the 11 years following the FDA warnings, the agency has received 139 additional reports of problems related to circumcision clamps, including 51 injuries.<ref>{{REFnews | |url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | ||
| last=Hennessy-Fiske | |title=Injuries linked to circumcision clamps | ||
| first=Molly | |date=2011-09-26 | ||
|publisher=Los Angeles Times | |||
| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports... | ||
| title=Injuries linked to circumcision clamps | |accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews | ||
| date=2011-09-26 | |last=Hennessy-Fiske | ||
| publisher=Los Angeles Times | |first=Molly | ||
| quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports... | |url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | ||
| accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews | |title=Injuries linked to circumcision clamps | ||
| last=Hennessy-Fiske | |date=2011-09-26 | ||
| first=Molly | |publisher=Los Angeles Times | ||
|quote=Twenty-one of those reports were related to Mogen clamps... | |||
| url=http://www.latimes.com/health/la-he-circumcision-20110926,0,4367816.story | |accessdate=2011-09-25}}</ref> | ||
| title=Injuries linked to circumcision clamps | |||
| date=2011-09-26 | |||
| publisher=Los Angeles Times | |||
| quote=Twenty-one of those reports were related to Mogen clamps... | |||
| accessdate=2011-09-25}}</ref> | |||
== Products & Devices == | == Products & Devices == | ||
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On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities.<ref>{{REFweb | On the 13 December 2011, the OIG published a report critical of the FDA's failure to oversee States inspection of food facilities.<ref>{{REFweb | ||
| last= | |last= | ||
| first= | |first= | ||
| date=December 2011 | |date=December 2011 | ||
| title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430) | |title=Vulnerabilities in FDA's Oversight of State Food Facility Inspections Report (OEI-02-09-00430) | ||
| url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf | |url=http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf | ||
| publisher= | |publisher= | ||
| accessdate=2011-12-16 | |accessdate=2011-12-16 | ||
}}</ref> The report read in part: | }}</ref> The report read in part: | ||