Main Medical Product Safety Network (MedSun) is an adverse event reporting network of approximately 350 hospitals established to facilitate the identification, comprehension, and resolution of adverse events due to problems with the use of medical devices. Participants use an Internet-based system that is designed to be an easy and secure way to report adverse medical device events. MedSun is an invaluable tool that aids in identifying unexpected side effects of devices that were not observed during the premarket testing, and in identifying an increase in the number of expected problems. This measure is an indicator of whether participating sites are effectively submitting reports (calculated as cumulative number of MedSun reports submitted divided by cumulative average number of participating MedSun hospitals). <i>Information is current as of September 30, 2012</i> Cumulative Average line 0 Cumulative Annual Target Measure was implemented starting FY 2012. April through September FY 2011 data provided as baseline.

Apr 2011 1.13 May 2011 2.26 Jun 2011 3.24 Jul 2011 4.40 Aug 2011 5.68 Sep 2011 6.87 0 Cumulative Annual Target Cumulative FY 2012 Target: 15 reports per hospital by 9/30/2012

FY 2012 Cumulative Average Overall: 15.26

Oct 2011 15 1.32 Nov 2011 15 2.57 Dec 2011 15 3.79 Jan 2012 15 4.88 Feb 2012 15 6.09 Mar 2012 15 7.22 Apr 2012 15 8.44 May 2012 15 9.55 Jun 2012 15 10.82 Jul 2012 15 12.01 Aug 2012 15 13.79 Sep 2012 15 15.26 Sub Cumulative average number of MedSun reports submitted per hospital Cumulative Number column 0 Cumulative Annual Target Measure was implemented starting FY 2012. April through September FY 2011 data provided as baseline.

Apr 2011 421 May 2011 842 Jun 2011 1,209 Jul 2011 1,645 Aug 2011 2,090 Sep 2011 2,474 0 Cumulative Annual Target

FY 2012 Cumulative Total: 4,904

Oct 2011 453 Nov 2011 881 Dec 2011 1,298 Jan 2012 1,673 Feb 2012 2,092 Mar 2012 2,482 Apr 2012 2,869 May 2012 3,220 Jun 2012 3,592 Jul 2012 3,943 Aug 2012 4,475 Sep 2012 4,904 Sub Cumulative average number of MedSun reports submitted per hospital Number column 0 600 Target Measure was implemented starting FY 2012. April through September FY 2011 data provided as baseline.

Apr 2011 421 May 2011 421 Jun 2011 367 Jul 2011 436 Aug 2011 445 Sep 2011 384 0 600

FY 2012 Total: 4,904

Oct 2011 453 Nov 2011 428 Dec 2011 417 Jan 2012 375 Feb 2012 419 Mar 2012 390 Apr 2012 387 May 2012 351 Jun 2012 372 Jul 2012 351 Aug 2012 532 Sep 2012 429 Sub Cumulative average number of MedSun reports submitted per hospital Number column 0 600 Target Measure was implemented starting FY 2012. April through September FY 2011 data provided as baseline.

Apr 2011 372 May 2011 373 Jun 2011 375 Jul 2011 377 Aug 2011 344 Sep 2011 320 0 600 Target

Oct 2011 342 Nov 2011 343 Dec 2011 343 Jan 2012 344 Feb 2012 345 Mar 2012 345 Apr 2012 317 May 2012 317 Jun 2012 293 Jul 2012 294 Aug 2012 286 Sep 2012 287 Sub Cumulative average number of MedSun reports submitted per hospital Cumulative Average Number column 0 600 Cumulative Annual Target Measure was implemented starting FY 2012. April through September FY 2011 data provided as baseline.

Apr 2011 372 May 2011 373 Jun 2011 373 Jul 2011 374 Aug 2011 368 Sep 2011 360 0 600 Cumulative Annual Target

FY 2012 Cumulative Average Overall: 321

Oct 2011 342 Nov 2011 343 Dec 2011 343 Jan 2012 343 Feb 2012 343 Mar 2012 344 Apr 2012 340 May 2012 337 Jun 2012 332 Jul 2012 328 Aug 2012 324 Sep 2012 321 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard track?program=cdrh&id=CDRH-OSB-Average-MedSun-reports-submitted-per-hospital Average number of MedSun reports submitted per hospital during the month track?program=cdrh&id=CDRH-OSB-Percent-MedSun-hospitals-in-program-for-11-months-submitted-3-reports-in-past-12-months Percent of MedSun hospitals (in program for at least 11 months) which have submitted at least 3 reports in previous 12 months ਍††਍਍਍਍਍਍਍