FDA.reportPublic FDA data

MAUDE MDR 3466140

MDR report key
3466140
Report number
1018233-2013-09110
Event key
0
Event type
3
Date received
2013-11-07
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#

Contact
REBE HUCKABY
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 LIMITEDFTLNABRD400HKHUSH1443R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-0701. R

Event Narratives#

D

Patient 1

THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED UNABLE TO VOID DESPITE URGE, SEPARATION OF THE PERINEAL BODY, LOSS OF EXTERNAL ANAL SPHINCTER INTEGRITY, INDURATED TISSUE, DRAINAGE, LOSS OF CONSORTIUM, PAIN, INFECTION, URINARY PROBLEMS, AND DYSPAREUNIA.

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS 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)".