InjuryOPT

ELEVATE PROLAPSE REPAIR SYSTEM

Received Jan 8, 2013

Report 2183959-2013-00130 · MDR key 2909772

Device

Generic name

Surgical Mesh

Manufacturer

American Medical Systems, Inc.

Product problems

Device Operates Differently Than Expected

Patient

Not reported

Emotional Changes
Disability

Narrative

Additional Manufacturer Narrative

LAWYER-FILED REPORT- (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND A PROBLEM WITH THE PRODUCT. THE DEVICE WAS IMPLANTED FOR TREATMENT.