MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 10INX10IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMLI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Obstruction/Occlusion (2422); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2020.It was reported that the patient experienced chronic pain, inflammation, swelling, bowel obstruction and gastrointestinal malfunction.
Additional Manufacturer Narrative
Appropriate term / code not available (e2402) utilized to capture gastrointestinal malfunction.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.Mwr-05042023-0001383825 submitted for adverse event which occurred on (b)(6) 2019.Mwr-06042023-0001383879submitted for adverse event which occurred on (b)(6) 2020.
Additional Manufacturer Narrative
Date sent to the fda: 4/17/2023.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Additional Manufacturer Narrative
Date sent to the fda: 7/21/2023.Additional b5 narrative: it was reported that the patient underwent local wound exploration on (b)(6) 2019 due to wound infection and abscess.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 10INX10IN
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16704604
• Report Number: 2210968-2023-02520
• Device Sequence Number: 17585598
• Product Code: FTL
• UDI-Device Identifier: 10705031050488
• UDI-Public: 10705031050488
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2023

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: 11/30/2022
• Device Model Number: SPMLI
• Device Catalogue Number: SPMLI
• Device Lot Number: LPP531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/16/2023; 07/11/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/18/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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 Age: 56 YR
• Patient Sex: Female