FDA.reportPublic FDA data

MAUDE MDR 376615

MDR report key
376615
Report number
1018233-2002-00001
Event key
0
Event type
3
Date of event
2001-12-10
Date received
2002-02-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
VIVIAN STEPHENS, MANAGER
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD PELVICOL ACELLULAR COLLAGEN MATRIXPORCINE DERMAL TISSUETISSUE SCIENCE LABORATORIESFTLNA482027UNKK992556YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-02-1101. R

Event Narratives#

D

Patient 1

DR. BELIEVED PT DEVELOPED INFECTION 1 WEEK POST-OPERATION. PT DEVELOPED PURULENT VAGINAL DRAINAGE. ENTIRE ANTERIOR WALL WAS OPEN, PELVICOL EXPOSED. VAGINA SEPARATING A LITTLE. ABDOMINAL INCISION LOOKED BAD. PT WAS TREATED WITH ANTIBIOTICS AND "HOMONES". CURRENTLY ABDOMINAL INCISION AND VAGINAL INCISION HAS HEALED. NO RECURRENT INCONTINENCE. ONSET OF INFECTION WAS IN 2001. PT WAS TREATED PERI-OPERATIVE WITH ANCEF. NO CULTURES WERE PERFORMED. PT WAS TREATED W/ABDOMINAL INCISION INFECTION AT THE SAME TIME. WEEK COURSE OF CLEOCIN VAGINAL CREME FOLLOWED BY DAILY ESTROGEN CREME. 2.0 VICRYL SUTURES WERE USED.