MAUDE Adverse Event Report: ETHICON INC. POSTERIOR PELVIC FLOOR REPAIR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP01

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Cramp(s) (2193)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2007.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2012.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and mesh was implanted due to symptomatic rectocele, enterocele, incomplete vaginal vault prolapse, and adhesions.It was reported that the patient experienced bleeding, pelvic wall prolapse, erosion, cramps in lower pelvic area, pelvic pain, urinary infections, problems when urinating, recurrent vaginal pain, urinary incontinence, urinary retention, and wound healing problems.It was reported that patient underwent mesh removal on (b)(6) 2007, (b)(6) 2010 due to mesh exposure, and (b)(6) 2012.No additional information was provided.

• Brand Name: POSTERIOR PELVIC FLOOR REPAIR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8806620
• MDR Text Key: 151553980
• Report Number: 2210968-2019-84458
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2007
• Device Catalogue Number: PFRP01
• Device Lot Number: 2998225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 111