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 exhibited urinary symptoms and urinary retention.A foley catheter was removed, but the claimant was unable void.They experienced urinary retention and mild abdominal tenderness in the suprapubic area.Cystoscopy and excision of the suburethral sling under general anesthesia for voiding dysfunction and incomplete emptying.
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