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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 PHY0715R
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 05/20/2011
Event Type  Injury  
Event Description

It was reported that a patient underwent an open ventral/incisional hernia repair procedure on (b)(6) 2011 and mesh was used. On (b)(6) 2011, the patient presented with abdominal pain and a high white blood cell count. The patient developed an intrabdominal infection that was (b)(6). The patient underwent reoperation on (b)(6) 2011 and seroplueralant fluid on the visceral side and parietal side of mesh was observed. The mesh was explanted. Currently, the patient is intubated in icu with sepsis. The surgeon opines the cause of the patient and (b)(6) event was renal failure at time of reported symptoms on (b)(6) 2011.

 
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. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

 
Manufacturer Narrative

(b)(4).

 
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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 Key2127446
Report Number2210968-2011-00780
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2011
Device Catalogue NumberPHY0715R
Device LOT NumberCK9DTHZ0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date05/20/2011
Device Age6 mo
Event Location Other
Date Manufacturer Received06/16/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2010
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: 06/15/2011 Patient Sequence Number: 1
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