FDA / MAUDE Adverse Event Report - Coloplast Virtue Male Sling

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male_sling_problems
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Date Joined Nov 2009
Total Posts : 134
   Posted 11/12/2009 9:22 PM (GMT -6)   
MAUDE - Manufacturer and User Facility Device Experience
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Adverse Events

11 records meeting your search criteria returned - Manufacturer: coloplast Brand Name: virtue Report Date From: 01/01/2009 Report Date To: 09/30/2009
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Manufacturer Brand Name Date Report Received
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/14/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/08/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 09/03/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/20/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 08/19/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 07/21/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 07/21/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/30/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/02/2009
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 06/02/2009

male_sling_problems
Regular Member


Date Joined Nov 2009
Total Posts : 134
   Posted 11/15/2009 11:05 PM (GMT -6)   
Page 2 of FDA / MAUDE Adverse Event Report

Manufacturer Brand Name Date Report Received
COLOPLAST MANUFACTUR VIRTUE VENTRAL URETH 04/01/2009

All 11 reports were classified as INJURY requiring intervention.

I need to file my report which will raise the total to 12 Adverse Events.

These numbers seem alarmingly high to me considering the short time that the Coloplast Virtue sling has been in use, the relatively small number of Coloplast Virtue slings implanted to date and knowing there could be others, suffering from injury and/or pain like myself, that has not yet filed a report.
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