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

Catalog Number PHY0715R

Device Problem Hole In Material (1293)

Patient Problems Adhesion(s) (1695); Pain (1994); Scarring (2061); Hernia (2240); No Code Available (3191)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to fda: 05/11/2017.(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 underwent a laparoscopic incisional hernia repair on (b)(6) 2015 and mesh was implanted.On (b)(6) 2016, the patient had to undergo a revision surgery due to complications, and found to have incarcerated omentum, recurrent hernia, pain, and complication from adhesions requiring lysis.The mesh was examined and found to have a hole centrally with mesh circumferentially and was well embedded along the wound, which was debrided back.No additional information was provided.

Manufacturer Narrative

Patient codes: (b)(4).It was reported that following insertion the patient experienced scarring.

• Brand Name: PHYSIOMESH RECTANGULAR
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 6560700
• MDR Text Key: 74948373
• Report Number: 2210968-2017-60217
• 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,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHY0715R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• 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
• Patient Age: 56 YR