FDA Adverse Event Injury Summary report: N

GYNECARE TVT RETROPUBIC SYSTEM

MDR report key: 3252786 · Received July 29, 2013

Report

Report Number: 2210968-2013-14961
Event Type: Injury
Date Received: July 29, 2013
Report Date: November 2, 2017
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K012628
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT SUI AND A RIGHT OVARIAN CYST AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF AN OVARIAN CYSTECTOMY PERFORMED DURING MESH IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative · 1

(B)(4). CONCLUSION: 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

IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Additional Manufacturer Narrative · 1

DATE SENT TO THE FDA: 07/04/2016.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
352722	GYNECARE TVT RETROPUBIC SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTN	ETHICON INC.	UNK	3020877

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention