MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Model Number	PMH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Scar Tissue (2060); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.Mwr-24102022-0001284190 submitted for adverse event which occurred on (b)(6) 2007.Mwr-24102022-0001284189 submitted for adverse event which occurred on (b)(6) 2011.Mwr-24102022-0001284188 submitted for adverse event which occurred on (b)(6) 2013.Mwr-24102022-0001284187 submitted for adverse event which occurred on (b)(6) 2014.Mwr-24102022-0001284186 submitted for adverse event which occurred on (b)(6) 2015.Mwr-24102022-0001284185 submitted for adverse event which occurred on (b)(6) 2020.
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent partial removal surgery and recurrent hernia repair surgery on (b)(6) 2007.It was reported that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2013 due to abdominal abscess and adhesions.It was reported that the patient underwent hernia repair surgery, laparotomy with extensive enterolysis and partial small bowel resection on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2020 during which the surgeon noted dense intra-abdominal adhesions and bowel erosion resulting in small bowel obstruction with subsequent small bowel resection.It was reported that the patient experienced severe pain, inflammation, scarring, bulging, loss of appetite, stress and anxiety.Other procedure is captured under separate file.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 11/06/2022.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 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo, PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15664914
• Report Number: 2210968-2022-08725
• Device Sequence Number: 20450780
• Product Code: FTL
• UDI-Device Identifier: 10705031049017
• UDI-Public: 10705031049017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 01/31/2011
• Device Model Number: PMH
• Device Catalogue Number: PMH
• Device Lot Number: XBP958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2006
• 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