The product was not considered as "released" at the moment of detection.Internal complaint reference number: (b)(4).Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the device did not cause or contribute to a death or serious injury, nor has it been implicated by a physician as having caused such injury.It was determined that the reported event happened in a smith and nephew facility and is considered under smith and nephew control and not released for distribution, not complying with the definition of complaint.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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