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 Adhesion(s) (1695); Nausea (1970); Pain (1994)

Event Type  Injury  

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.(b)(4) submitted for adverse event which occurred on (b)(6) 2007.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2007 during which the surgeon noted extensive bowel adhesions and a hernia inferior to the old ventral hernia repair.The extensive adhesions were taken down.It was reported that the patient underwent surgery on (b)(6) 2019 during which the surgeon noted the mesh firmly adherent to bowel loops with multiple areas in which the small bowel and mesh were fused.After several hours of tedious dissection, an area of perforated small bowel with puss and stool content were discovered.He resected the small bowel and repaired multiple areas of deserosalization that occurred during the extensive lysis of adhesions.The abscess cavity was irrigated and the sharp edges of any exposed mesh were debrided.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.

Manufacturer Narrative

Date sent to the fda: 1/27/2022.

• 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
• MDR Report Key: 11654222
• MDR Text Key: 245996329
• Report Number: 2210968-2021-03288
• 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,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2022
• 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