D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.D5.Other operator of device: operator of device is unknown.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # mw5150083.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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