Unknown manufacturer: a catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, smiths medical corporate headquarters in oakdale, mn has been listed in sections d3.And g1.And the oakdale fda registration number has been used for the manufacture report number.B3.Date of event: month and year of event have been provided, but day is unknown.D4.Catalog, lot number, udi, expiration date and h4.Manufacture date are unknown; no information has been provided to date.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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