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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 PHY2535V
Event Type  Injury  
Event Description

It was reported by a patient that the patient underwent a hernia repair procedure on an unknown date and mesh was used. Approximately one year after the procedure, the patient experienced a relapse. A second procedure was performed on an unknown date and the mesh was removed. The surgeon reported that the mesh was not incorporated in the abdominal wall and was adherent to the small intestine. Additional information was requested.

 
Manufacturer Narrative

(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records for the batch number was conducted and the batch met all finished goods release criteria.

 
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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
GM  NI
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville , NJ 08876
9082182708
MDR Report Key2707404
Report Number2210968-2012-04287
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 08/03/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2013
Device Catalogue NumberPHY2535V
Device LOT NumberDC8MPZA0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/03/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2011
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: 08/21/2012 Patient Sequence Number: 1
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