FDA.report

MAUDE MDR 266572

MDR report key
266572
Report number
266572
Event key
0
Event type
3
Date of event
2000-01-28
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 AND CYSTOCELE REPAIR USING A BOVINE PERCARDIAL PATCH. POST-OP, THE PT WAS TREATED FOR INTERMITTENT URINARY TRACT INFECTIONS BUT NO EROSION OF THE SLING. HOWEVER IN 01/2000 PT HAD BLEEDING AND UPON EXAM THE PREVIOUSLY HEALING INCISION WAS OPEN WITH THE GRAFT EXPOSED AND EVIDENCE OF INFECTION WAS PRESENT. IN 2000 PT HAD GRAFT REMOVED AND UNDERWENT BLADDER NECK RECONSTRUCTION.

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