B3 - date of event estimated as 04/01/2024 d4 - a partial udi was provided as the lot number is not known the device was not returned for analysis.A corrective and preventive actions (capa) review was performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database could not be conducted because the lot number was not provided.As the device was not returned for analysis the investigation was unable to determine a conclusive cause for the reported difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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