FDA Adverse Event Summary report: N

APOGEE POLYPYRIDINE MESH

MDR report key: 855513 · Received May 24, 2007

Report

Report Number
MW5001945
Date Received
May 24, 2007
Date of Event
June 14, 2006
Report Date
May 24, 2007
Manufacturer
TM SYSTEMS WITH INTEL PRO
Product Code
FTL
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

REPORTER IS PATIENT WHO STATES THAT, APPROXIMATELY ONE YEAR AGO IN JUNE, HER RECTUM PERTRUDED TO HER VAGINAL AREA AND AS A RESULT, SHE REQUIRED SURGERY WITH THE PLACEMENT OF THE MESH DEVICE. THREE MONTHS POST-OPERATIVELY, THE PATIENT EXPERIENCED RECTAL BLOOD CLOTS AND INABILITY TO SIT. SHE RECALLS LOTS OF DRAINAGE OF BOTH PUS AND BLOOD. THIS REQUIRED THAT SHE RECEIVE A SECOND SURGERY TO CORRECT THE PROBLEM (IN THAT SAME YEAR). THE REPORTER (SURGICAL) STATED THAT, THERE WAS "EXCESS TISSUE WITH MORE TENSION THAN ANTICIPATED" IN THE AREA OF THE MESH. THE SURGEON HAD TO CUT THE ADHESION IN ORDER TO RELIEVE THE TENSION. IN THE FOLLOWING YEAR (2007), A HOLE APPEARED IN HER RECTAL AREA. IT FELT ALMOST AS IF IT WERE "CONCRETE". SHE SOUGHT A SECOND OPINION FROM ANOTHER PHYSICIAN WHO DESCRIBED THE SITE AS BEING "LIKE A BAR" GOING ACROSS HER REAR. SHE HAS HAD SEVERAL COMPLICATIONS TO INCLUDE HEART RATE, IRREGULARITIES FOR WHICH SHE ASSOCIATES WITH THE MESH DEVICE. SHE'S HEARD ABOUT THE RECALL OF THE KUGEL MESH, BUT IS UNSURE IF THE SAME CAN BE ASSOCIATED WITH THE DEVICE SHE HAS. HOWEVER, SHE IS EXPERIENCING SOME OF THE SAME SIDE EFFECTS. SHE'S BEEN UNABLE TO RETURN TO WORK, BUT SHE MUST RETURN IN ORDER TO RECEIVE 100% OF HER BENEFITS. SHE SEES HER DOCTOR EVERY COUPLE OF WEEKS AND SHE GETS PAIN SHOTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 APOGEE POLYPYRIDINE MESH SURGICAL MESH FTL TM SYSTEMS WITH INTEL PRO TM-724D4212 446375025

Patients

Seq Age Sex Outcome Treatment
1 48 YR