As reported to coloplast, though not verified, legal representative stated the patient with this device experienced stress urinary incontinence, mechanical dysfunction of genitourinary device and device exposure in right sulcus.Patient had explantation of the device and cystourethroscopy with urethral dilation via general anesthesia.
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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.
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Additional information received on 5/1/2023 as follows: the patient was caused to suffer, and did suffer, the serious and dangerous side effects of erosion of the vaginal wall and other tissues, permanent and substantial physical deformity and loss of the ability to perform sexually and has undergone corrective surgeries that will likely require a further collective surgery, and suffered further grievous personal injuries, including, but not limited to, physical pain and mental anguish, permanently diminished enjoyment of life, and any and all additional life implications and complications such as the patient's need for life-long medical treatment and care.
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