The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that the dressing was creased and this failure has not caused any serious injury in this case or in a patient before, 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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