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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 - 2012

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TimeTargetPercent
Oct 20119099
Nov 20119098
Dec 20119092
Jan 20129095
Feb 20129096
Mar 20129090
Apr 20129093
May 20129092
Jun 20129099
Jul 20129096
Aug 20129097
Sep 201290100

FY 2012 Overall: 97%

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A585
Nov 2011N/A506
Dec 2011N/A545
Jan 2012N/A578
Feb 2012N/A592
Mar 2012N/A617
Apr 2012N/A484
May 2012N/A448
Jun 2012N/A580
Jul 2012N/A565
Aug 2012N/A526
Sep 2012N/A2,731

FY 2012 Total: 8,757

Total number of death MDRs reviewed during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A588
Nov 2011N/A514
Dec 2011N/A590
Jan 2012N/A608
Feb 2012N/A615
Mar 2012N/A683
Apr 2012N/A519
May 2012N/A488
Jun 2012N/A587
Jul 2012N/A586
Aug 2012N/A543
Sep 2012N/A2,734

FY 2012 Total: 9,055

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.