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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL

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ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Catalog Number PHY2025V
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Conclusion: a photo of the actual explanted mesh device was evaluated. There was a lack of tissue incorporation in the mesh. The mechanism for the underlying the early separation of the mesh could not be determined.

 
Event Description

It was reported that a patient underwent a laparoscopic hernia repair procedure on (b)(6) 2012 and mesh was used. Twenty days post operatively, the patient experienced severe inflammation due to the foreign body mesh and developed an recurrent incisional hernia. The patient underwent a reoperation on (b)(6) 2012. During the reoperation, adhesions were found and the mesh was covered with a thick and whitish rind, which could be the neoperitoneum, with white bubbles, also present on the colon, as further evidence of excessive inflammatory reaction developed by the patient. The mesh was completely and easily removed because it was not integrated at all. A different type of mesh was used to repair the hernia. Currently, the patient is getting better.

 
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.

 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
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 Key2639885
Report Number2210968-2012-02567
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPHY2025V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/25/2012
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

Patient TREATMENT DATA
Date Received: 07/05/2012 Patient Sequence Number: 1
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