MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number	PCDL1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Vomiting (2144); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2016 during which the surgeon noted the mesh had separated from the right lateral aspect of the hernia defect.It was reported that the patient experienced mesh shrinkage, mesh separation, adhesions, abdominal pain and discomfort.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 06/11/2021.Additional b5 narrative: it was reported that the patient experienced vomiting following the surgery.
Additional Manufacturer Narrative
Date sent to fda: (b)(6) 2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10816712
• Report Number: 2210968-2020-08867
• Device Sequence Number: 2113569
• Product Code: FTL
• UDI-Device Identifier: 10705031047747
• UDI-Public: 10705031047747
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020

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: 12/31/2006
• Device Model Number: PCDL1
• Device Catalogue Number: PCDL1
• Device Lot Number: XHG361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/19/2020; 06/10/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 11/24/2020; 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR