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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 Hole In Material (1293)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient underwent an umbilical hernia repair surgery on (b)(6)2014 and physiomesh (10cm x 15cm) was implanted. It was reported that patient underwent mesh removal on (b)(6)2016 by (b)(6)due to adhesion.
 
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 an umbilical hernia repair surgery on an undisclosed date and mesh was implanted. On (b)(6) 2015, the patient underwent another surgery due to a recurrence, and it was determined that the mesh had ruptured in the center. Another mesh was implanted. The patient experienced persistent abdominal pain and had another surgical procedure on (b)(6) 2016. Both mesh devices, which were noted to be unincorporated, were removed. No additional information is provided at this time.
 
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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 Key6432647
MDR Text Key105835807
Report Number2210968-2017-60138
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/05/2018
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: 03/24/2017 Patient Sequence Number: 1
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