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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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced recurrent mixed urinary incontinence, incomplete emptying, increased frequency, device exposure at bladder neck, pelvic pain, perianal pain, introital dyspareunia, bilateral buttock pain, stress urinary incontinence with activity, palpable sutures in anterior vaginal wall and deep in the vagina.Post operatively after implant, the patient was sent home with a foley catheter.The patient had explantation of the device, urethrolysis, anterior repair, and paravaginal defect repair.Interoperative findings noted two pieces of mesh material with a scant amount of adherent gray-tan tissue measuring 5.5 x 0.6 x 0.1 to 0.3 and 2.5 x 0.5 x 0.2 cm.
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