MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH; MESH, SURGICAL

Device Problem Hole In Material (1293)

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

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 a patient underwent a hernia repair procedure on an unknown date and mesh was implanted.It was found that the mesh had a hole in the middle of the defect and the patient experienced a recurrent hernia as a result.The recurrent hernia had to be fixed.No additional information was provided.

• Brand Name: PHYSIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D-228 51; GM D-22851
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6541731
• MDR Text Key: 74330649
• Report Number: 2210968-2017-60210
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• 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