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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC
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ETHICON, INC. PHYSIOMESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1515Q
Event Type  Injury  
Event Description

It was reported that a patient underwent hernia repair procedure on an unknown date and mesh was used. The patient experienced a recurrent hernia. The reoperation took place on (b)(6) 2012. During the procedure it was noted that the mesh was found pushed together approximately one centimeter away from the hernial orifice. Additional information has been requested.

 
Manufacturer Narrative

(b)(4). Device (b)(4) - recurrent hernia occurred. 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, INC.
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
GERMANY NI
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville , NJ 08876
9082182708
MDR Report Key2704678
Report Number2210968-2012-04170
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 07/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/17/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPHY1515Q
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/23/2012
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

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