MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL ULTRAPRO MESH MESH, SURGICAL, POLYMERIC

Catalog Number UMM1

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

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

Event Date 11/23/2016

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 right inguinal hernia repair procedure on unknown date more than one year ago and the mesh was implanted using a liechtenstein technique. It was also reported that during a second surgery, the mesh was found ruptured in two halves/parts. One half of the mesh was fixed and integrated to oblique minor and the other half was in strip and between both there was a recurrent hernia. The surgeon opined that the alleged product failure is manifested during the second surgical intervention due to re-occurrence and one year of placement evidences the state of the recidivism/relapse, the rupture of the mesh and the conservation, still of the ambirisable material. No further information is available.

• Brand Name: ULTRAPRO MESH
• 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: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6178803
• MDR Text Key: 62520001
• Report Number: 2210968-2016-60108
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UMM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2016
• 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 Treatment Data

Date Received: 12/15/2016 Patient Sequence Number: 1

Treatment

3-0PROLENE SUTURE