MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 12INX14IN; MESH, SURGICAL, POLYMERIC

Catalog Number	SPMXXL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994); Vomiting (2144); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that patient underwent hernia revision surgery on (b)(6) 2022 and mesh was implanted.It was reported that patient experienced undisclosed adverse events.It was reported that patient had hernia repair surgery on (b)(6) 2014 and mesh was implanted.Other procedure was captured in a separate file.
Additional Manufacturer Narrative
Date sent to the fda: 8/12/2024.D4: udi: as the catalog/model number was not provided, the (01) gtin is 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.
Additional Manufacturer Narrative
Date sent to the fda: 10/28/2024.Additional b5 narrative: it was reported that the patient experienced bulge at the umbilicus causing pain, nausea, vomiting and discomfort.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 12INX14IN
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19959940
• Report Number: 2210968-2024-08337
• Device Sequence Number: 7064982
• Product Code: FTL
• UDI-Device Identifier: 10705031050518
• UDI-Public: (01)10705031050518
• Combination Product (Y/N): N
• Initial Reporter Country: ZI
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: SPMXXL
• Device Lot Number: MHR769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male