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.