FDA.reportPublic FDA data

MAUDE MDR 2665341

MDR report key
2665341
Report number
1018233-2012-00799
Event key
0
Event type
3
Date of event
2012-06-20
Date received
2012-07-19
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
RENE HUCKABLY
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 LIMITEDFTLNABRD400HKHUVH1507* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-1901. R

Event Narratives#

D

Patient 1

IT WAS REPORTED BY THE PT'S DOCTOR THAT WHILE MAKING A PASS DURING A T.O.T. PROCEDURE, THE CONNECTOR BROKE OFF FROM THE NEEDLE INSIDE OF THE PT. THE DOCTOR WAS UNABLE TO COMPLETE THE PROCEDURE AND HAD TO CUT THE MESH IN ORDER TO REMOVE THE DEVICE. IT IS UNK AS TO HOW MUCH MESH REMAINS IN THE PT. AN ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

N

Patient 1

THE DEVICE HAS BEEN RETURNED AND HAS BEEN SENT TO THE MANUFACTURING SITE FOR EVALUATION. ONCE THE EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICE CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. PERFORATION OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).