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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH MESH, SURGICAL Back to Search Results
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 the patient underwent an unknown hernia repair procedure on unknown date and the mesh was implanted. Approximately two years after the procedure, the patient had a recurrence of hernia. This was found during a pre-op visit for an abdominoplasty procedure and it was unknown if the patient had been experiencing any symptoms of the hernia recurrence or if it was found as a part of the normal pre-op check procedure. During the abdominoplasty procedure, the surgeon found that there was a hole in the center of the mesh. The mesh was removed and replaced with biologic mesh. No further information is available.
 
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Brand NamePHYSIOMESH
Type of DeviceMESH, 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
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6218326
MDR Text Key63728673
Report Number2210968-2017-60002
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/12/2016
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: 01/03/2017 Patient Sequence Number: 1
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