Lot: ak070042.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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.Device not returned.
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As reported to coloplast, though not verified the patient experienced vaginal discharge, fatigue, pelvic pain, vomiting, utis, mild bladder prolapse (confirmed via ct scan), abnormal vaginal bleeding, hematuria, urinary frequency/urgency/dysuria, nocturia, urethral hypermobility, grade i rectocele, mild vaginal atrophy, dyspareunia, bladder neck/urethral foreign body/erosion, feeling of vaginal bulge and incomplete bladder void, urinary incomitance, and foreign body protruding through vagina.The device was excised.
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