OMNISURE MESH

MDR report key: 3840717 · Received January 30, 2014

Report

Report Number: 2125050-2014-00146
Event Type: Injury
Date Received: January 30, 2014
Date of Event: October 11, 2012
Report Date: January 30, 2014
Manufacturer: COLOPLAST A/S
Product Code: FTL
PMA / PMN Number: K092207
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

Description of Event or Problem · 1

AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH OMNISURE MESH. LATER THE PATIENT EXPERIENCED INCONTINENCE, INFECTION, PAIN, DYSPAREUNIA, BLEEDING, MESH EROSION AND FIBROCONNECTIVE TISSUE WITH FOREIGN BODY. AN EXCISION OF THE MESH, ANTERIOR VAGINAL WALL REPAIR WITH NATIVE TISSUE AND CYSTOSCOPY WERE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
65920	OMNISURE MESH	SURGICAL MESH	FTL	COLOPLAST A/S	5166001400

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other