FDA Adverse Event Injury Summary report: N

ALIGN TO URETHRAL SUPPORT SYSTEM

MDR report key: 2831772 · Received November 9, 2012

Report

Report Number: 1018233-2012-01770
Event Type: Injury
Date Received: November 9, 2012
Report Date: October 17, 2012
Manufacturer: BARD SHANNON LIMITED
Product Code: FTL
PMA / PMN Number: K070073
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE REMAINS IMPLANTED. 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. 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, SEROMA, WHICH MAY OCCUR FOLLING 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. PERFORATIONS 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).

Description of Event or Problem · 1

THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2012-01771.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALIGN TO URETHRAL SUPPORT SYSTEM		FTL	BARD SHANNON LIMITED	NA	HUSF1805

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM-ANTERIOR