MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number	UHSL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent left inguinal hernia repair on (b)(6) 2009 and mesh was implanted.It was reported that the patient experienced pain, swelling, and tenderness along the previous scar.It was previously reported that the patient had recurrent right inguinal hernia repair on (b)(6) 2008 and mesh was implanted.Other procedure was captured in a separate file.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 11/22/2024.H6: appropriate term / code not available (e2402) utilized to capture tenderness.D4: udi: as the lot number for the device involved in the event was for dhr review, the full udi is currently not available.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.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: ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY
• 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: 20757656
• Report Number: 2210968-2024-12340
• Device Sequence Number: 21205669
• Product Code: FTL
• UDI-Device Identifier: 10705031132450
• UDI-Public: (01)10705031132450
• Combination Product (Y/N): N
• Initial Reporter Country: ZI
• PMA/510(K) Number: K071249
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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 Catalogue Number: UHSL
• Device Lot Number: AG8LXA1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male