MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT+M ANTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRA02

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 04/30/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure.The diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the left anterior mesh exposure first noted by a physician? when was the right anterior mesh exposure first noted by a physician? mesh exposure site/location, symptoms, and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.What is the patient's current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2012 and mesh was implanted.The patient experienced left anterior and right anterior mesh exposure on unknown dates.The patient further experienced dyspareunia, pain and bleeding and underwent complete mesh excision on (b)(6) 2020.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to fda: (b)(6) 2021.Additional information: d1, d4, h4, h6.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Date sent to fda: (b)(6) 2021.Corrected information: d4, g4.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GYNECARE PROLIFT+M ANTERIOR
• 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: 10905048
• MDR Text Key: 219168546
• Report Number: 2210968-2020-09270
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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: 10/31/2014
• Device Catalogue Number: PFRA02
• Device Lot Number: 3595463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention