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.The date of revision was estimated.
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As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pain with daily activities, infections, scarring, physical deformity, severe emotional pain, apprehension of increased risk of injuries, device exposure, discharge and surgical revision of the device.
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Correction: item number, health impact code.Additional information: lot number al100095.Deleted: udi number.The lot number was reviewed for complaint trend, nonconforming (nc) report, and capa.No ncs nor capas were identified.Devices met specification.
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