MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT; MESH, SURGICAL

Catalog Number PHY1520R

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); 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 by an attorney that the patient had mesh implanted laparoscopically to repair a ventral hernia on (b)(6) 2011.On (b)(6) 2013, the patient had to undergo a revision surgery due to complications.She was found to have infected mesh which was loose and not incorporated into the anterior abdominal wall, recurrent hernia, pain, with adhesion complications.No additional information was provided.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.,.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): JOHNSON & JOHNSON INTERNATIONAL; leonardo da vincilaan 15; diegem 1831 ; BE 1831
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 6642874
• MDR Text Key: 77623504
• Report Number: 2210968-2017-60270
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: PHY1520R
• Device Lot Number: DH8JGBA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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
• Patient Age: 52 YR