(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported unsealed device packaging.It should be noted the unsealed device packaging could not be confirmed as the device was discarded by the account and not returned for analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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