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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 PHY2030R
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
Event Description

It was reported that a patient underwent an incisional hernia repair on an unknown date and mesh was used. The patient developed an ileus. During reoperation, heavy ingrowth of the mesh and bowel was noted. The bowel could only be separated from the mesh with sharp instrument. The mesh was removed. The ileus was repaired by skin closure and no new mesh was placed. An additional surgery for hernia repair with mesh is planned after four to six weeks.

 
Manufacturer Narrative

(b)(4): 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 Key2217482
Report Number2210968-2011-01135
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHY2030R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/04/2011
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: 08/19/2011 Patient Sequence Number: 1
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