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 Abscess (1690); Cyst(s) (1800); Fistula (1862); Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 the adverse event which occurred on (b)(6) 2007.(b)(4) submitted for the adverse event which occurred on (b)(6) 2011.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery and debridement of abdominal wall abscess on (b)(6) 2007 during which the surgeon noted ¿a big mass formation with the cystic area with large amount of fluid in the cavity, which was excised, along with the previously placed mesh.Debridement was done around the tissue.A wound vac was placed in order to try to clear the fluid formation in the debridement and a plastic dressing was placed.¿ it was reported that the patient underwent recurrent hernia repair, exploratory laparotomy, lysis of adhesions, debridement of abdominal wall, and small bowel obstruction on (b)(6) 2011 during which the surgeon noted ¿the small bowel was densely adherent to the previously placed mesh.There was a purulent fluid encountered consistent with abscess and infection of the anterior abdominal wall mesh.The mass was then excised.¿ it was reported that the patient experienced severe pain, infection, abscess, fistula, bulging, inflammation, stress and anxiety.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 05/20/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROCEED MESH 6INX6IN(15CMX15CM) SQ
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11721788
• MDR Text Key: 249717768
• Report Number: 2210968-2021-03748
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: 10705031047754
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Model Number: PCDM1
• Device Catalogue Number: PCDM1
• Device Lot Number: XGG233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention