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

Model Number PCDT1

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569)

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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted ¿the intestine was densely adherent to the mesh to the point that it was extremely difficult to dissect this free.Sharp dissection was used to go a layer at a time until we encountered patch material directly adherent to the bowel wall.The bowel was markedly distended and that pieces of mesh were stuck into the bowel wall.Unfortunately, dissection resulted in the patient suffering a perforation in the bowel.¿ 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: 10/1/2021 additional information: a2, b7 additional b5 narrative: it was reported that the patient experienced small bowel obstruction.

Manufacturer Narrative

Date sent to the fda: 10/25/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11742283
• MDR Text Key: 248072068
• Report Number: 2210968-2021-03971
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047785
• UDI-Public: 10705031047785
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: PCDT1
• Device Catalogue Number: PCDT1
• Device Lot Number: CEG261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR