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

Model Number PCDJ1

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

Patient Problems Inflammation (1932); Scarring (2061); Hernia (2240)

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) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent lysis of adhesions on (b)(6) 2011 during which the surgeon noted extensive adhesions of the small bowel to the underside of the mesh.The adhesions were taken down using sharp dissection for approximately one hour before visualization of the sigmoid colon could be achieved.It was reported that the patient underwent recurrent incisional hernia repair surgery on (b)(6) 2018 during which the surgeon noted the hernia defect appeared to be located within an area where the previously placed mesh had torn.There was a 4 cm defect noted on the mesh itself.The previously placed mesh was revised.It was reported that the patient experienced severe pain, dense adhesions, scarring, inflammation, loss of appetite, stress and anxiety.No additional information is provided.

Manufacturer Narrative

Date sent to fda: 09/29/2020.Corrected information: d4 (catalog).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 02/09/2021.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10587567
• MDR Text Key: 208573811
• Report Number: 2210968-2020-07115
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047730
• UDI-Public: 10705031047730
• 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,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: PCDJ1
• Device Catalogue Number: PCDH1
• Device Lot Number: BEG266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR