Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information a definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.
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