FDA Adverse Event Injury Summary report: N

GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

MDR report key: 3222280 · Received July 12, 2013

Report

Report Number: 2210968-2013-12900
Event Type: Injury
Date Received: July 12, 2013
Report Date: July 5, 2016
Manufacturer: ETHICON INC.
Product Code: OTP
PMA / PMN Number: K071512
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE AND LARGE LATERAL CYSTOCELE WITH ANTERIOR DEFECT.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 EXCISION OF VAGINAL MESH, EXCISION OF THE MIDURETHRAL MESH, REPAIR OF BLADDER NECK FISTULA, AND AUTOLOGOUS FASCIA PUBOVAGINAL SLING ON (B)(6) 2015.

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
323027	GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC	OTP	ETHICON INC.	UNK	2995671

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention