FDA Adverse Event Injury Summary report: N

GYNECARE TVT OBURATOR SYSTEM

MDR report key: 3222803 · Received July 12, 2013

Report

Report Number: 2210968-2013-12975
Event Type: Injury
Date Received: July 12, 2013
Report Date: June 29, 2018
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K033568
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). 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

(B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH LAP ASSISTED VAGINAL HYSTERECTOMY/BSO, A&P REPAIR, CYSTOSCOPY ON (B)(6) 2008 DUE TO SUI, POP, CYSTOCELE AND MESH WAS IMPLANTED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Additional Manufacturer Narrative · 1

IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2018 DUE TO URINARY FREQUENCY AND URINARY URGENCY. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 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
322656	GYNECARE TVT OBURATOR SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTN	ETHICON INC.	UNK	3041481

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Required Intervention