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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 PHY1520V
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 a laparoscopic surgical procedure on (b)(6) 2010 to repair a ventral hernia and mesh was implanted. The patient experienced a recurrent hernia on an unknown date. The patient underwent an open hernia repair procedure (b)(6) 2011. During the procedure, the mesh was very easily removed because it was hardly attached to the peritoneum with almost no ingrowth. A different mesh was used complete the repair procedure.

 
Manufacturer Narrative

(b)(4). Recurrent hernia. Conclusion: the product upon which this medwatch is based is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

 
Manufacturer Narrative

(b)(4). Results: the explanted mesh showed the non-resorbable, large pore, monofilament polypropylene mesh which shows minimal foreign body reaction. The immunohistochemical detection of the peritoneum on both the visceral and parietal side of mesh indicates that the mesh has not been placed flat against the abdominal wall. A relation to the used fixation (absorbatacks) cannot be drawn. Conclusion- the recurrence seems to be due to inadequate fixation as in the histological examination peritoneum cells were found on both sides of the mesh.

 
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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 Key2070827
Report Number2210968-2011-00517
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,Followup
Report Date 04/04/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHY1520V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/25/2011
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Other
Date Manufacturer Received05/25/2011
Was Device Evaluated By Manufacturer? Yes
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: 04/27/2011 Patient Sequence Number: 1
Treatment
ABSORBATACK
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