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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL, INC BARD VISILEX MESH SIZE 4.5 INCHES XREF 0112910 6 INCHES

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DAVOL, INC BARD VISILEX MESH SIZE 4.5 INCHES XREF 0112910 6 INCHES Back to Search Results
Catalog Number 0112910
Event Date 03/18/2008
Event Type  Injury  
Event Description

In 2003, pt had bilateral inguinal hernia repair with mesh. Bard visilex mesh was used on his right and left sides. In 2008, pt presented with prostate cancer for a radical prostatectomy. Unfortunately, the anterior aspect of the bladder was very adherent to the mesh, and we were unable to get an adequate plane between the detrusor and the mesh. Because of this significant anterior adherence, the surgeon did not feel we could safely proceed with prostatectomy. The pt was closed and radiation therapy was recommended.

 
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Brand NameBARD VISILEX MESH
Type of DeviceSIZE 4.5 INCHES XREF 0112910 6 INCHES
Manufacturer (Section D)
DAVOL, INC
warwick RI
MDR Report Key1232231
Report NumberMW5008990
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/13/2008
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0112910
Device LOT Number43END199
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

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