The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot identified one similar complaint from this lot for this potential product quality issue therefore it is associated to the exception.The complaint investigation determined that the label on the complaint device was not created by abbott west distribution center (awdc) or abbott vascular netherlands (avn).The label font, format and content do not match the approved label, aal2107322-01.Therefore, there is no product quality issue with respect to the design, manufacture or labeling of the device.The other four rx viatrac plus devices referenced are filed under separate medwatch report numbers.
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