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

Model Number PCDN1

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

Patient Problems Diarrhea (1811); Nausea (1970); Chills (2191)

Event Type  Injury  

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) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted.It was reported that the patient underwent partial removal surgery on (b)(6) 2019 during which the surgeon noted the mesh was exposed and he removed the exposed portion as the remainder of the mesh could not be excised or removed.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted he discovered and took down the adhesions between the small bowel and peritoneum.The surgeon then found infected mesh cavity, which was debrided and removed.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, constipation, inflammation, distended abdomen, swelling, pain and suffering.No additional information was provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11418443
• MDR Text Key: 234972631
• Report Number: 2210968-2021-02019
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047761
• UDI-Public: 10705031047761
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDN1
• Device Catalogue Number: PCDN1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• 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