MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	UMS3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Prolapse (2475)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure were any concomitant procedures performed? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? when was the mesh exposure first noted by a physician? please confirm the mesh exposure site/location and symptoms.Describe any medical/surgical intervention for the exposure and recurrent prolapse including dates and findings.What is the physician¿s opinion as to the etiology of or contributing factors to this event of exposure and recurrent prolapse? 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.H6 component code: g07002 ¿ device not returned a review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent posterior pelvic floor repair in 2008 and mesh was inserted.In 2016, recurrence of prolapse was noted, normal findings at time, pessary management from there on and in.In 2022, identified to have suspicion of mesh exposure on posterior vaginal wall, undergone investigation and confirms mesh exposure.Asymptomatic patient, and only found incidentally given 6 monthly pessary changes.The device remains implanted in patient.Additional information has been requested.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20351741
• Report Number: 2210968-2024-10464
• Device Sequence Number: 8108224
• Product Code: FTL
• UDI-Device Identifier: 10705031085947
• UDI-Public: (01)10705031085947(17)121231(10)ZH8HMBR0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 12/31/2012
• Device Catalogue Number: UMS3
• Device Lot Number: ZH8HMBR0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2007
• 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: Other
• Patient Sex: Unknown