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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This follow-up mdr is created to document the additional patient and device information, and the conclusion of the investigation.Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.However, because quality's examination may not conclusively confirm or disprove the report of infection, quality accepts the physician's observations of such as the reason for surgical intervention.This device was released to specification by quality control.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, and because the device is not available for evaluation, no further corrective action is required at this time.
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