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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1015V
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Adhesion(s) (1695); 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 underwent a ventral hernia repair on an undisclosed date and mesh was implanted. On (b)(6) 2014, the patient underwent surgery for recurrence of incisional hernia. The operating physician noted that the mesh was densely and extensively adhered to omentum as well as to the patient¿s intestines. He underwent a prolonged surgical procedure to attempt to remove the mesh from his intestines and to remove the mesh that failed to incorporate into the abdominal facsia. No additional information was provided.

 
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Brand NamePHYSIOMESH OVAL
Type of DeviceMESH, 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 Key6439000
MDR Text Key71007843
Report Number2210968-2017-60142
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHY1015V
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 Received02/26/2018
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 TREATMENT DATA
Date Received: 03/28/2017 Patient Sequence Number: 1
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