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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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A titan otr pump, two cylinders, and a reservoir were received for evaluation.Because quality's examination of the returned components may not conclusively confirm or disprove the report of infection, quality did not perform a microscopic examination.Based on the information provided quality accepts the physician's observations of such as the reason for surgical intervention.The review of the device lot history records by quality assurance indicates this lot passed sterility testing prior to being released.Based on this knowledge, quality concludes that the device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than the device.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.
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