FDA Adverse Event Injury Summary report: N

GYNECARE TVT RETROPUBIC SYSTEM

MDR report key: 3253837 · Received July 30, 2013

Report

Report Number: 2210968-2013-15022
Event Type: Injury
Date Received: July 30, 2013
Report Date: July 11, 2016
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K012628
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, RECURRENCE, AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative · 1

(B)(4).

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 PATIENT UNDERWENT EVACUATION OF HEMATOMA AND COPIOUS LAVAGE OF THE ABDOMEN ON (B)(6) 2007 DUE TO APPARENT INFECTED HEMATOMA, CUFF ABSCESS AND POSSIBLE BOWEL PERFORATION. (B)(4).

Additional Manufacturer Narrative · 1

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356272	GYNECARE TVT RETROPUBIC SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTN	ETHICON INC.	UNK	1172996

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Required Intervention