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

Catalog Number PHY1015V

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422); Not Applicable (3189)

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) 2019, (b)(4) submitted for adverse event which occurred on (b)(6) 2019.

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 the patient underwent revision surgery on (b)(6) 2019.It was reported that an adhesions was found to the mesh which was took down and encountered a mass of coalesced small bowel.It was reported that the patient underwent removal surgery on (b)(6) 2019 where it was found half of the mid bowel was covered in thick rind causing adhesions.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 2/21/2021.Additional information: a2, b7, d1, d2a, d4.Additional b5 narrative: it was reported that the patient experienced abdominal pain and partial small bowel obstruction following the surgery.

Manufacturer Narrative

Date sent to the fda: (b)(6) 2021.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10482627
• MDR Text Key: 205295046
• Report Number: 2210968-2020-06603
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: PHY1015V
• Device Lot Number: CL8JTRA0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 02/18/2021; 02/24/2021
• Supplement Dates FDA Received: 02/21/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention