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

Model Number PCDT1

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Fistula (1862); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted a large defect in the abdomen and dense adhesions of the small bowel to the mesh. After removing the mesh, he encountered multiple enterocutaneous fistulae and was forced to perform a small bowel resection. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. No additional information was provided.

• 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
• MDR Report Key: 14031385
• MDR Text Key: 288773320
• Report Number: 2210968-2022-02442
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PCDT1
• Device Catalogue Number: PCDT1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• 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 Treatment Data

Date Received: 04/06/2022 Patient Sequence Number: 1