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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC

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ETHICON PHYSIOMESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1015V
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Hernia (2240); Surgical procedure (2357)
Event Date 04/01/2011
Event Type  Injury  
Event Description

It was reported that a patient underwent an open incision hernia repair procedure on (b)(6) 2011 and mesh was implanted. The patient experienced a recurrent hernia on (b)(6) 2011 and underwent a second open hernia repair procedure. During the procedure, it was found the mesh had come apart and unraveled.

 
Manufacturer Narrative

Date sent to the fda: 04/28/2011. (b)(4) - recurrent hernia. Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section G)
ETHICON GMBH & COMPANY KG
robert - koch - strasse 1
po box 1409
d-22851 norderstedt NI
GM NI
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville, NJ 08876
9082182708
MDR Report Key2072202
MDR Text Key1945299
Report Number2210968-2011-00530
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 Health Professional,User facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/07/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2011
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? Yes
Event Location Other
Date Manufacturer Received04/07/2011
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: 04/28/2011 Patient Sequence Number: 1
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