MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UND/BLU 6X11CM::; ABDOMINAL HERNIA SURGICAL MESH,COMPOSITE-POLYMER

Catalog Number	XCUMS3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Prolapse (2475)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure (b)(6) 2012 and mesh was implanted.The patient went to the clinic with recurrent prolapse and a 3 x 1 cm mesh exposure was found on posterior vaginal wall.No other symptoms were reported by the patient, incidental finding of mesh exposure.The patient will have the exposed mesh removed at repeat repair of posterior vaginal wall.Additional information has been requested.
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 gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? were any concurrent devices implanted? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? were there any intra-operative complications? please provide the mesh exposure symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.What is the physician¿s opinion as to the etiology of or contributing factors to this event? 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.

• Brand Name: ULTRAPRO MESH UND/BLU 6X11CM::
• Common Device Name: ABDOMINAL HERNIA SURGICAL MESH,COMPOSITE-POLYMER
• 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: 17927585
• Report Number: 2210968-2023-07710
• Device Sequence Number: 6350710
• Product Code: FTL
• UDI-Device Identifier: 10705031085947
• UDI-Public: 10705031085947
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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: 12/31/2016
• Device Catalogue Number: XCUMS3
• Device Lot Number: DM8MBMR0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2011
• 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 Age: 62 YR
• Patient Sex: Unknown