FDA.report

MAUDE MDR 266585

MDR report key
266585
Report number
266585
Event key
0
Event type
3
Date of event
2000-01-05
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*980826-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. POSTOP THE PT EXPERIENCED PERSISTENT URINARY RETENTION THAT FINALLY HAD TO BE MANAGED WITH USE OF A SUPRA PUBIC CATHETER. IN 2000, PT HAD GRAFT REMOVED, REPAIR OF CYSTOCELE 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