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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Pain (1994); Not Applicable (3189)

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.Psr-66133 submitted for adverse event which occurred on (b)(6) 2017.Psr-66132 submitted for adverse event which occurred on (b)(6) 2017.Mwr-27072020-0000772760 submitted for adverse event which occurred on (b)(6) 2016 mwr-27072020-0000772761 submitted for adverse event which occurred on (b)(6) 2016 mwr-27072020-0000772763 submitted for adverse event which occurred on (b)(6) 2018 mwr-27072020-0000772764 submitted for adverse event which occurred on (b)(6) 2018.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh were implanted. it was reported that she experienced pain, dysuria,  erosion of her internal bodily tissue and other injuries following the procedure. it was reported that the patient underwent excision surgery on (b)(6) 2016.It was reported that the patient experienced pain and vesicovaginal fistulas which required vaginal sling repairs on, (b)(6) 2017 and on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: (b)(6) 2020.Additional information: a1, e1.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10332121
• MDR Text Key: 202371583
• Report Number: 2210968-2020-05599
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR