MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH 6INX6IN(15CMX15CM) SQ; MESH, SURGICAL, POLYMERIC

Catalog Number	PCDM1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent repair of recurrent incarcerated incisional hernia on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery and laparotomy with extensive lysis of adhesion together with an abdominal anterior release on (b)(6) 2018 during which surgeon noted closed loop obstruction containing small bowel secondary to mesh, large scar unhealed, infected sore in the umbilicus and adhesions.It was reported that the patient underwent repair of recurrent incisional hernia and mesh removal on (b)(6) 2022 and mesh was implanted.It was reported that the patient underwent abdominal wound dehiscence, extraction of necrotic mesh and washout of the wound on (b)(6) 2022.It was reported that the patient experienced large scar unhealed, infected sore in the umbilicus and adhesions.Other procedure was captured in a separate file.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 8/22/2024.D4: udi: as the lot number for the device involved in the event was not provided, 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.Mwr-21082024-0001695691 submitted for adverse event which occurred on 12/19/2018.Mwr-21082024-0001695692 submitted for adverse event which occurred on 10/11/2022.Mwr-21082024-0001695693 submitted for adverse event which occurred on 10/25/2022.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: PROCEED MESH 6INX6IN(15CMX15CM) SQ
• 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: 20050750
• Report Number: 2210968-2024-08813
• Device Sequence Number: 8117991
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: (01)10705031047754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060713
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: PCDM1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/23/2024
• 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