Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that , the brown spots were seen before use on patient ,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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