(b)(4).Information was received from a foreign source who is not required to complete form 3500a.The product was not provided nor was a photo sent in for evaluation; therefore, the condition of the device unknown.The device history record review found this lot to be conforming; indicating the device was manufactured, inspected, and packaged to specifications.The device is used for treatment.A product history search found no other complaints against the related part and lot combination.With the information provided and without the actual device to examine, a definitive root cause cannot be determined.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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