GYNECARE TVT OBURATOR SYSTEM

Report

Report Number: 2210968-2013-14815
Event Type: Injury
Date Received: July 29, 2013
Report Date: July 17, 2013
Manufacturer: ETHICON INC.
Product Code: OTN
PMA / PMN Number: K033568
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, 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

DATE SENT TO THE FDA: 02/12/2014. THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT DYSFUNCTIONAL UTERINE BLEEDING, CHRONIC PELVIC PAIN, STRESS URINARY INCONTINENCE, MINIMAL CYSTOCELE AND RECTOCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF HYSTEROSCOPY, DILATION AND CURETTAGE AND NOVASURE ENDOMETRIAL ABLATION PERFORMED DURING MESH IMPLANTATION. AS PER OPERATIVE REPORT, IN 2012 THE SECOND MESH WAS PLACED WITHOUT THE REMOVAL OF THE FIRST MESH.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGERY ON (B)(6) 2008 AND (B)(6) 2012 AND MESH WAS IMPLANTED INTO THE PATIENT¿S BODY EACH TIME. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352054	GYNECARE TVT OBURATOR SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTN	ETHICON INC.		3554210

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention