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

Model Number PCDG1

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240)

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) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted the mesh had torn and resulted in a recurrent hernia. Adhesions of the mesh to the omentum and small bowel were found and infection later confirmed to be a foreign body giant cell reaction. It was reported that the patient experienced severe pain, scarring and inflammation. No additional information was provided.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted the mesh had torn and resulted in a recurrent hernia. Adhesions of the mesh to the omentum and small bowel were found and infection later confirmed to be a foreign body giant cell reaction. It was reported that the patient experienced severe pain, scarring 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.

• 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: 12833235
• MDR Text Key: 285474518
• Report Number: 2210968-2021-11627
• 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,Followup,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2012
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: CKG462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2010
• 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: 11/17/2021 Patient Sequence Number: 1