FDA Adverse Event Injury Summary report: N

GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

MDR report key: 3260688 · Received August 1, 2013

Report

Report Number: 2210968-2013-15502
Event Type: Injury
Date Received: August 1, 2013
Report Date: May 25, 2016
Manufacturer: ETHICON INC.
Product Code: OTP
PMA / PMN Number: K013718
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

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

ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2009 DUE TO MESH EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative · 1

DATE SENT TO THE FDA: 06/06/2016.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 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
360629	GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTP	ETHICON INC.	UNK	3245747

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention