After multiple attempts, the device was not returned for evaluation.Based on the lot number provided in the intial report of the complaint, this device was purchased in dec 2016 and had been in use for approximately 2 years at the time that the complaint was reported.Because the device not been returned, a root cause could not be determined, therefore, this can be seen as the final report.If additional information is obtained that alleges any additinal patient involvement or the need for corrective actions a follow-up report will be submitted.
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