ELEVATED ANTERIOR & APICAL PROLAPSE REPAIR

MDR report key: 2770348 · Received October 1, 2012

Report

Report Number: 2183959-2012-02793
Event Type: Injury
Date Received: October 1, 2012
Date of Event: November 30, 2010
Report Date: March 8, 2012
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
Product Code: FTL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

Description of Event or Problem · 1

RELATED TO MFR REPORT #2183959-2012-02794. THE PLAINTIFF WAS IMPLANTED WITH BIOARC SLING DURING SURGERY PERFORMED ON (B)(6), 2010 TO TREAT HER PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. IT WAS ALLEGED BY THE PLAINTIFF'S ATTORNEY THAT THE "PLAINTIFF HAS SUFFERED SEVERE AND PERMANENT BODILY INJURIES AND SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING." ON (B)(6), 2010 THE PLAINTIFF WAS REPORTED TO HAVE BEEN EVALUATED AND DIAGNOSED WITH "DYSPAREUNIA, VOIDING DYSFUNCTION, OTHER COMPLICATIONS DUE TO GENITOURINARY DEVICE IMPLANT AND GRAFT, PELVIC MUSCLE WEAKNESS AND ATROPHY." AND THE PLAINTIFF CONTINUES TO SUFFER FROM "SEVERE PELVIC PAIN, VAGINAL BLEEDING, DIFFICULTY URINATING, AND DYSPAREUNIA," AND OTHER DAMAGES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ELEVATED ANTERIOR & APICAL PROLAPSE REPAIR	SURGICAL MESH	FTL	AMERICAN MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability	BIOARC SLING SYSTEM