MAUDE Adverse Event Report: ETHICON INC. PHY2535V; MESH, SURGICAL, POLYMERIC

Catalog Number PHY2535V

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

Patient Problems Diarrhea (1811); Chills (2191); Decreased Appetite (4569)

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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent additional surgery on (b)(6) 2013 during which the surgeon noted: she took down adhesions between the mesh, omentum, and bowel.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted she lysed dense adhesions between the small bowel and the mesh, which took approximately an hour.It was reported that the patient experienced severe pain, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.It was reported that the patient is deceased.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 1/12/2021.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: 5/20/2021.

• Brand Name: PHY2535V
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11140034
• MDR Text Key: 225770269
• Report Number: 2210968-2021-00167
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: PHY2535V
• Device Lot Number: DC8BXXA1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention