FDA.report

MAUDE MDR 266590

MDR report key
266590
Report number
266590
Event key
0
Event type
3
Date of event
1999-10-05
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 REPAIR OF CYSTOCELE USING BOVINE PERICARDIAL PATCH GRAFT. POSTOP THE PT DEVELOPED BURNING ON URINATION AFTER RESUMING MARITAL RELATIONS EARLIER THAN ADVISED. IN 1999, PT HAD PERICARDIAL 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