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	Erosion (1750); Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (b)(6) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.
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 debridement surgery on (b)(6) 2008 and (b)(6) 2008 during which the surgeon noted the fascia had broken down and the mesh was exposed to the infection.The mesh would eventually need to be removed as it was exposed to the contamination of the abdominal wall cellulitis and abscess.It was reported that the patient underwent removal surgery on (b)(6) 2009 during which the surgeon noted two areas of exposed mesh and excised all exposed mesh.It was reported that the patient underwent debridement of remaining mesh on (b)(6) 2009 during which the surgeon noted debrided the wound down to the muscle, cleaned the wound and resected the remaining exposed mesh.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11536981
• Report Number: 2210968-2021-02593
• Device Sequence Number: 3931972
• Product Code: FTL
• UDI-Device Identifier: 10705031047747
• UDI-Public: 10705031047747
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2009
• 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): 03/18/2021

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: No Information
• Device Model Number: PCDL1
• Device Catalogue Number: PCDL1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/21/2021
• 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