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U.S. Department of Health and Human Services

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Percent of death Medical Device Reports (MDRs) reviewed within 5 business days during the month

Dictionary: OSB strives to review medical device adverse events resulting in death within 5 business days of receiving the submission. Timely review of death MDRs can minimize widespread failure of the device, thereby limiting the loss of life due to similar events as the one submitted.

Information is current as of September 30, 2013

Fiscal Year - 2011

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TimeTargetPercent
Oct 20109097
Nov 20109097
Dec 20109099
Jan 20119099
Feb 20119099
Mar 20119099
Apr 20119099
May 201190100
Jun 20119099
Jul 20119099
Aug 201190100
Sep 20119099

FY 2011 Overall: 99%

Number of death MDRs reviewed within 5 business days during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A411
Nov 2010N/A445
Dec 2010N/A629
Jan 2011N/A515
Feb 2011N/A687
Mar 2011N/A2,177
Apr 2011N/A942
May 2011N/A935
Jun 2011N/A622
Jul 2011N/A535
Aug 2011N/A697
Sep 2011N/A680

FY 2011 Total: 9,275

Total number of death MDRs reviewed during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A423
Nov 2010N/A458
Dec 2010N/A637
Jan 2011N/A521
Feb 2011N/A691
Mar 2011N/A2,200
Apr 2011N/A950
May 2011N/A936
Jun 2011N/A626
Jul 2011N/A543
Aug 2011N/A698
Sep 2011N/A685

FY 2011 Total: 9,368

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.