FDA.reportPublic FDA data

MAUDE MDR 356671

MDR report key
356671
Report number
1018233-2001-00023
Event key
0
Event type
3
Date received
2001-10-18
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 LABORATORIES, PLCFTLNA482212UNKK992556YRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-10-1801. R

Event Narratives#

D

Patient 1

FIVE PTS ALLEGEDLY DEVELOPED POST-OP INFECTIONS WHERE SUTURES EXIT AT ABDOMINAL SKIN SITE WITHIN A FEW DAYS OF HAVING A PUBOVAGINAL SLING PROCEDURE PERFORMED. CULTURES WERE GRAM NEGATIVE AND THERE WERE NO INFECTIONS IN THE VAGINAL AREA OF ANY OF THE PTS. FOUR PTS DEVELOPED CELLULITIS. ONE HAD STAPH AUREUS/ABSCESS. INFECTIONS HAVE OCCURRED WITHIN THE LAST 6 WEEKS TO 2 MONTHS. ANTIBIOTICS HAVE BEEN PRESCRIBED AND APPEAR TO BE WORKING. DR. WILL CONTINUE TO MONITOR AND USE PELVICOL. PTS ARE TREATED WITH ANTIBIOTICS 1 TO 1 AND 1/2 HOURS PRIOR TO SURGERY (KESSOL IV). VICRYL SUTURES WERE USED ON ALL FIVE PTS.