FDA Adverse Event Injury Summary report: N

AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

MDR report key: 2875275 · Received December 13, 2012

Report

Report Number: 1018233-2012-02023
Event Type: Injury
Date Received: December 13, 2012
Report Date: November 14, 2012
Manufacturer: C.R. BARD, INC. (COVINGTON)
Product Code: FTL
PMA / PMN Number: K082571
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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 REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

Description of Event or Problem · 1

THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDRS: 1018233-2012-02022, 1018233-2012-02027, AND 1018233-2012-02021.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR		FTL	C.R. BARD, INC. (COVINGTON)	NA	CVRI0041

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	PELVICOL ACELLULAR COLLAGEN MATRIX\| ALIGN TO URETHRAL SUPPORT SYSTEM\| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR