Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Lot number ah060050.
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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced vaginal dryness, reduced libido, constipation, irregular bowel habit, abdominal bloating, ovarian cysts, abdominal pain, back pain, loose stools, bowel incontinence, frank incontinence, diarrhea, bowel urgency, fibromyalgia, groin pain, groin abscesses, urinary tract infections, strong smelling urine, dyspareunia, stress incontinence, urge incontinence, post micturition dribble, vaginal bleeding, vaginal pain, piles, vaginal discharge, leg pain, dysuria, frequency, recurrent thrush and patient has been affected psychologically.
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