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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cramp(s) (2193); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This medwatch report is in response to receipt of maude event report mw5064569.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/abdominal wall reconstruction on (b)(6) 2013 and the mesh was implanted.The patient experienced cramping, motility issues, abdominal cramps and constipation.The patient also underwent a mesh removal on (b)(6) 2016.No further information is available.

Manufacturer Narrative

This medwatch report is being voided as it is a duplicate of medwatch report #: 2210968-2016-04969.Please see medwatch report # 2210968-2016-04969 for all information regarding this event.

• 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: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 6055184
• MDR Text Key: 58315421
• Report Number: 2210968-2016-60057
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• 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