MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH 6INX6IN(15CMX15CM) SQ; MESH, SURGICAL, POLYMERIC

Model Number PCDM1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Scar Tissue (2060); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney 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.The patient had a previous mesh implanted on (b)(6) 2007 and mesh implanted on (b)(6) 2011 which is captured in a separate files.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 10/24/2022.(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.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.

• Brand Name: PROCEED MESH 6INX6IN(15CMX15CM) SQ
• Type of Device: 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: 15664418
• MDR Text Key: 302324908
• Report Number: 2210968-2022-08702
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: 10705031047754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDM1
• Device Catalogue Number: PCDM1
• Device Lot Number: HGD070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male