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

Catalog Number PHY1015V

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Hernia (2240); No Code Available (3191)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a ventral hernia repair procedure on an unknown date and mesh was implanted.The patient underwent a reoperation for a recurrent hernia and the surgeon removed the mesh.During the re-operation, the doctor noticed that the mesh was completely unfixed in the patient and essentially balled up.The surgeon opines that they coating on both sides of the mesh is inhibiting tissue in growth.The procedure was completed using a different type of mesh.Additional information was requested.

• Brand Name: PHYSIOMESH OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5250319
• MDR Text Key: 32128962
• Report Number: 2210968-2015-19157
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2015

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 Catalogue Number: PHY1015V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention