FDA Adverse Event Injury Summary report: N

GYNECARE TVT RETROPUBIC SYSTEM

MDR report key: 3242524 · Received July 23, 2013

Report

Report Number: 2210968-2013-14106
Event Type: Injury
Date Received: July 23, 2013
Report Date: July 6, 2016
Manufacturer: ETHICON INC.
Product Code: FTL
PMA / PMN Number: K974098
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative · 1

IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY TRACT INFECTION.

Additional Manufacturer Narrative · 1

(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO CYSTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, HIVES, PERFORATION OF BLADDER AND BLADDER PROBLEMS WITH SCARRING TO NEARBY ORGANS. IT WAS REPORTED PATIENT UNDERWENT LASER LITHOTRIPSY AND RESECTION OF EROSION OF VAGINAL MESH IN SEPTEMBER 2011. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012. IT WAS REPORTED PATIENT UNDERWENT HIP REPLACEMENT ON (B)(6) 2012 FOR ARTHRITIS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
343142	GYNECARE TVT RETROPUBIC SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	FTL	ETHICON INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention