Uroplasty is conservatively reporting each occurrence of this malfunction as a separate mdr based on the lack of information surrounding the incident, as well as the potential for the device to require explantation.The incidents were reported together directly to the (b)(4) competent authority (tga) and the reporter wished to remain anonymous.Uroplasty has contacted the distributor multiple times in an attempt to acquire additional information that could aid in performing an investigation, however due to privacy laws in (b)(6), very limited information on the actual incidents has been made available.Based on the information we were able to obtain, uroplasty is unable to discern what the potential cause of the erosion of the bulking agent is, however should further information be made available, we plan to update this report accordingly.
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Three patients in (b)(6) presented with potential complications possibly related to prior implantation of macroplastique.Each patient had macroplastique implanted years earlier and presented with recurrent incontinence and urinary tract infections.For each patient, the reporter noted that the bulking material was said to have been exposed/eroded through the epithelium of the bladder neck and/or urethra.The doctor tried to explant the material, however if was said the macroplastique was impossible to remove.
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