FDA Adverse Event Injury Summary report: N

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

MDR report key: 3240038 · Received July 18, 2013

Report

Report Number: 1018233-2013-02884
Event Type: Injury
Date Received: July 18, 2013
Report Date: June 19, 2013
Manufacturer: BARD SHANNON LTD
Product Code: FTL
PMA / PMN Number: K082571
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 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. 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, WHICH MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

Description of Event or Problem · 1

COMPLAINT # (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED. ASSOCIATED MDR #S: 1018233-2013-02883 AND 1018233-2013-02885.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
333446	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR		FTL	BARD SHANNON LTD	NA	HUSD2138R

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention	PRODUCT# 482152, LOT# CVSA0015\| PELVILACE TO BIOURETHRAL SUPPORT SYSTEM:\| PRODUCT# 486100, LOT# HUSF0392\| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR