FDA.report

MAUDE MDR 266582

MDR report key
266582
Report number
266582
Event key
0
Event type
3
Date of event
2000-01-12
Date received
2000-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Report source
U
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHELHIGHBOVINE PERICARDIAL PATCHSHELHIGHMFXSHP 555 315*980904-SHPY*

Patients

SequenceReceivedTreatmentOutcome
12000-02-2401. R

Event Narratives

D

Patient 1

IN 1999, PT UNDERWENT TRANSVAGINAL FASCIAL SLING FOR STRESS INCONTINENCE WITH USE OF BOVINE PERICARDIAL PATCH. POSTOP PT HAD NO INCONTINENCE AND WAS HEALING WELL EXCEPT FOR A SMALL AREA THAT DID NOT CLOSE COMPLETELY BUT NO GRAFT EXPOSED. IN 2000, PT BEGAN HAVING VAGINAL DISCHARGE, DESPITE TREATMENT WITH ANTIBIOTICS THIS DID NOT IMPROVE. IN 2000, PT HAD GRAFT REMOVED AND UNDERWENT REPAIR OF SURGICAL SITE.

Related GUDID Devices By Product Code

No records found.

Related PMN/PMA Records By Product Code

TypeSubmissionProduct codeDeviceApplicantDecision date
510(k)K061727MFXGORE PRECLUDE VESSEL GUARDW. L. Gore & Associates, Inc.2006-08-07
510(k)K960532MFXPRECLUDE IMA SLEEVEW. L. Gore & Associates, Inc.1996-05-23