MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH; MESH, SURGICAL, POLYMERIC

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent exploratory laparoscopy on (b)(6) 2020 during which the surgeon noted small bowel obstruction and extensive adhesiolysis to take down adhesions of omentum and bowel from the mesh.Once the majority of the anterior abdominal wall adhesions were taken down, he explored the small bowel and found extensive dense adhesions and the obstruction.Further adhesiolysis was performed to ensure that all bowel was released.It was reported that the patient underwent laparotomy surgery on (b)(6) 2021 during which the surgeon noted his bowels were glued to the other together by fibrous adhesions and this required again a slow careful meticulous dissection.Distal jejunum was quite chewed up from the dissection and also where this segment had been adherent to the undersurface of the anterior abdominal wall and mesh.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.

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) 2020.(b)(4); submitted for adverse event which occurred on (b)(6) 2021.

• Brand Name: PROCEED MESH
• 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: 12993490
• MDR Text Key: 286467696
• Report Number: 2210968-2021-12553
• 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: Other
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2021
• 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
• Patient Sex: Male