As reported to coloplast, though not verified, legal representative stated the patient with this device experienced an emergency room visit for abnormal vaginal bleeding, foreign body of vagina, unable to have intercourse due to ¿something in the vagina¿, vaginal pain, stress urinary incontinence, urge incontinence and an abnormal urinalysis.Patient had partial explantation of the device and cystoscopy.Intraoperative findings noted the exam under anesthesia revealed a small area of about 3 mm x 6 mm that showed exposed urethral device.A 2 cm segment of device overlying the urethra was transected.
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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.
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