MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	PMH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a laparoscopic sacral colpopexy with posterior vaginal repair, division of adhesions and cystoscopy on (b)(6) 2009 and mesh was implanted.In 2013, patient had mesh erosion requiring surgical intervention and on the (b)(6) 2013 patient had an anterior vaginal repair with excision of mesh erosion, cystoscopy and suprapubic cystotomy.In 2023, the patient presented to the mesh clinic with a 3 year history of pv bleeding and infections that was affecting her quality of life.On (b)(6) 25 patients had an eua and cystoscopy which found a 1cm tunnel tracking up r side of the vagina another 2-3cm.No mesh palpable in this, tiny sinus noted at top of the tunnel, no obvious mesh or suture seen.Mri in 2023 showed inflammatory change at the distal mesh at the level of the vaginal vault supporting mesh failure/exposure and the anterior rectal wall tethers to the distal mesh vaginal vault attachment.On the (b)(6) 25 patients required an examination under anesthesia, vaginal excision of sacrocolpopexy mesh, vaginal revision and cystourethroscopy.During this surgery they found at the vaginal vault a 2cm area of exposed mesh, with large amount of granulation tissue overlying the mesh exposure site.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No further information available as reporter details have not been disclosed (confidential).
Additional Manufacturer Narrative
Product complaint #(b)(4).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.Additional information: h4, h6 type of investigation.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24225380
• Report Number: 2210968-2026-01154
• Device Sequence Number: 15794232
• Product Code: FTL
• UDI-Device Identifier: 10705031049017
• UDI-Public: (01)10705031049017(17)140128(10)BCP888
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2014
• Device Catalogue Number: PMH
• Device Lot Number: BCP888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown