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	Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Hernia (2240); Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that during surgery on (b)(6) 2014 the surgeon noted some omental adhesions in the right side of abdomen to the right side of previously placed mesh left she had some fascial stay suture and appeared one of these had pulled through like it was a small swish cheese hernia causing small defect.It was reported that the patient experienced abdominal pain, bulge and adhesions.It was reported that the patient underwent recurrent ventral incisional hernia repair with mesh on (b)(6) 2017 during which mesh had torn causing a recurrence in the mid portion of the mesh containing small bowel and preperitoneal fat.It was reported that the patient had lysis of adhesion, recurrent ventral hernia repair on (b)(6) 2018.It was reported that the patient underwent recurrent incisional hernia repair with mesh, intra abdominal adhesive disease, partial small bowel obstruction on (b)(6) 2022.It was reported that the patient had nausea, abdominal pain and adhesions.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 10/8/2024 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.(b)(4) submitted for adverse event which occurred on 09/14/2017.((b)(4) submitted for adverse event which occurred on 4/13/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20396642
• Report Number: 2210968-2024-10589
• Device Sequence Number: 11635928
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: (01)10705031047754(17)160831(10)HKG204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 10/08/2024

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 Expiration Date: 08/31/2016
• Device Catalogue Number: PCDM1
• Device Lot Number: HKG204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2014
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: Black Or African American