FDA Adverse Event Injury Summary report: N

MESH

MDR report key: 2838061 · Received November 7, 2012

Report

Report Number: 2183959-2012-02981
Event Type: Injury
Date Received: November 7, 2012
Report Date: October 16, 2012
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
Product Code: FTL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

IT IS UNK WHAT AMS INCONTINENCE MESH PRODUCT WAS IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. INTERNATIONAL UROLOGYNECOLOGY JOURNAL OCTOBER 2012, ARTICLE TITLE: MANAGEMENT OF TWO SYNTHETIC MIDURETHRAL SLINGS ERODED INTO THE URETHRAL LUMEN. HTTP://RD.SPRINGER.COM/ARTICLE/10.1007/S00192-012-1944-3.

Description of Event or Problem · 1

RELATED TO MFR REPORT# 2183959-2012-02983. RELATED TO MFR REPORT# 2183959-2012-02984. THE INTERNATIONAL UROGYNECOL JOURNAL REPORTED 5 ADDITIONAL CASES OF ERODED MESH IN THE URETHRA. AN EXCISION SURGERY UTILIZING A HOLMIUM LASER WAS PERFORMED IN ALL 5 ADDITIONAL CASES. PT OUTCOME REVEALED ALL 5 CASES HAD SUCCESSFUL ELIMINATION OF ERODED MESH IN THE URETHRAL LUMEN. SURGICAL DATES WERE NOT PROVIDED. CONTINENCE RATE IN ALL 5 ADDITIONAL CASES HAS BEEN PRESERVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MESH	SURGICAL MESH	FTL	AMERICAN MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R\| S