MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Catalog Number SPMII

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

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) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and two (2) mesh products were implanted, due to pelvic organ prolapse and urinary incontinence.It was reported that the patient experienced recurrent urinary incontinence, vaginal bleeding, inflamed cervix, recurrent urinary tract infections, dyspareunia, chronic pain, foul smelling discharge, erosion of the mesh into her vaginal wall, and erosion of the other mesh into her cervix and adherence to her bowel.It was reported that the patient underwent surgical procedures on (b)(6) 2019 and (b)(6) 2020 to remove the products.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 06/08/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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.

Manufacturer Narrative

Date sent to the fda: 3/26/2024.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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: PROLENE SOFT MESH 3INX6IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14199086
• MDR Text Key: 293299414
• Report Number: 2210968-2022-02952
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031050471
• UDI-Public: 10705031050471
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: SPMII
• Device Lot Number: EAP023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female