22,335
edits
Changes
Jump to navigation
Jump to search
m
Fixed date format error.
|publisher=Los Angeles Times
|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
|last=Hennessy-Fiske
|first=Molly
|publisher=Los Angeles Times
|quote=Instead of recalling the devices, the FDA advised users to make sure...
|accessdate=2011-09-25}}</ref> The agency also cautioned against using replacement parts on the Gomco clamp, which led it to malfunction.<ref>{{REFnews
|last=Hennessy-Fiske
|first=Molly
|publisher=Los Angeles Times
|quote=The agency also cautioned against using replacement parts on the Gomco clamp...
|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
|last=Hennessy-Fiske
|first=Molly
|publisher=Los Angeles Times
|quote=In the 11 years following the FDA warnings, the agency has received 139 additional reports...
|accessdate=2011-09-25}}</ref> Twenty-one of those reports were related to [[Mogen]] clamps, all but one of which involved injuries.<ref>{{REFnews
|last=Hennessy-Fiske
|first=Molly
|publisher=Los Angeles Times
|quote=Twenty-one of those reports were related to Mogen clamps...
|accessdate=2011-09-25}}</ref>
== Products & Devices ==
| last=
| first=
| date=March 2012-03
| title=Report Slams Approval Process for Medical Devices
| url=http://www.webcitation.org/66VuXY3Us
| last=
| first=
| date=July 2012-07
| title=FDA Conducted Surveillance Operation Against Scientists
| url=http://www.webcitation.org/69DN3PuxD
|last=
|first=
|date=December 2011-12
|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
| last=
| first=
| date=June 2012-06
| title=Scientific Disagreements Regarding Medical Device Regulatory Decisions (Report OEI-01-10-00470)
| url=http://oig.hhs.gov/oei/reports/oei-01-10-00470.pdf