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

Catalog Number PCDG1

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Chills (2191); Hernia (2240); Bowel Perforation (2668)

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2018 during which the surgeon noted he had to spend an hour and half lysing adhesions of old mesh to the omentum and small bowel.The small intestines were excised from the remainder of the mesh and the interloop adhesions were freed.The previously placed mesh has bunched up in the right side.The entirety of the mesh was removed.It was reported that the patient experienced severe pain, infections, chills, inflammation, loss of appetite and severe weight loss.No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 9/9/2020.Additional h6 patient code: 3191 - mesh migration.Additional b5 narrative: it was reported that the patient experienced abdominal pain, bowel perforation, mesh migration, and hernia recurrence following surgery.

Manufacturer Narrative

Date sent to the fda: 9/18/2020.Additional information: d4, h4.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.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10138867
• MDR Text Key: 194660009
• Report Number: 2210968-2020-04446
• Device Sequence Number: 1
• Product Code: FTL
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: PCDG1
• Device Lot Number: HPG253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100