MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH 20X25V; ABDOMINAL HERNIA SURGICAL MESH, COMPOSITE-POLYMER

Model Number	PHY2025V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Chills (2191); Decreased Appetite (4569)
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) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2021 during which the surgeon noted the mesh was noted to be densely adherent to the bowel.The adhesions were so severe that portions of the bowel had to be removed along with the mesh.It was reported that the patient experienced severe pain, extensive adhesions, infection, small bowel resection, abdominal wall abscess, chills, inflammation and loss of appetite.No additional information was provided.
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.

• Brand Name: ETHICON PHYSIOMESH 20X25V
• Common Device Name: ABDOMINAL HERNIA SURGICAL MESH, COMPOSITE-POLYMER
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16230860
• Report Number: 2210968-2023-00468
• Device Sequence Number: 6475477
• Product Code: FTL
• UDI-Device Identifier: 10705031132344
• UDI-Public: 10705031132344
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 01/23/2023

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 Model Number: PHY2025V
• Device Catalogue Number: PHY2025V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female