FDA.report

MAUDE MDR 266576

MDR report key
266576
Report number
266576
Event key
0
Event type
3
Date of event
2000-01-21
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*980826-SHPY*

Patients

SequenceReceivedTreatmentOutcome
12000-02-2401. R

Event Narratives

D

Patient 1

IN 1999, PT UNDERWENT TRANSVAGINAL FASCIAL SLING AND CYSTOCELE REPAIR USING PERICARDIAL PATCH. DESPITE MILD RESIDUAL URINE INCISION WAS HEALED AND PT RELEASED TO NORMAL ACTIVITY INCLUDING MARITAL RELATIONS. IN 01/2000, PT HAD BLEEDING AND VAGINAL DISCHARGE. EXAM SHOWED GRAFT TO BE EXPOSED WITH EVIDENCE OF INFECTION. IN 2000, PT HAD GRAFT REMOVED AND 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