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

Catalog Number PHY1520V

Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)

Patient Problems Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a hernia repair procedure on an unknown date and mesh was implanted.Approximately 3 to 4 months after the procedure, the patient experienced unspecified symptoms.The patient underwent a second procedure where it was noted that the hernia had recurred and the mesh was torn.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 9/4/2019.

• Brand Name: ETHICON PHYSIOMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7000881
• MDR Text Key: 91055293
• Report Number: 2210968-2017-70795
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY1520V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2019
• 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