As reported to coloplast, though not verified, legal representative stated the patient with this device experienced device exposure, device protrusion, bleeding, infections, pelvic floor disfunction, pelvic pain, vaginal pain, dyspareunia, urinary urgency problems, scarring, and difficulty with daily activities.The patient had the device explanted.
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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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