FDA.reportPublic FDA data

MAUDE MDR 3475918

MDR report key
3475918
Report number
1018233-2013-09189
Event key
0
Event type
3
Date received
2013-11-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

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
1ALIGN TO URETHRAL SUPPORT SYSTEMBARD SHANNON LIMITEDFTLNABRD500HLHUSD0715R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-0801. R

Event Narratives#

D

Patient 1

THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PT UNDERWENT LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, TRANSOBTURATOR TAPE, POSTERIOR REPAIR, LAPAROSCOPIC LYSIS OF ADHESIONS, AND CYSTOSCOPY.

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4). LAWYER-FILED REPORT - (B)(6).