The event date was set on (b)(6) 2020 as it was the day the damage was reported to us.However, the shipment was in transit from (b)(6) 2020, therefore the event may have occurred between these two dates.The device was not made available to the manufacturer.The distributor preferred to keep the goods.According to the complainant, transport problem identified.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.However, another product was damaged in the same delivery (complaint #(b)(4)).A mdr is submitted in parallel for this other product.The most likely cause of this event is an inappropriate handling of the parcel during transport.An internal non-conformity report has been initiated in order to take appropriate actions if necessary.Please note the presence of the following mention on the instructions for use: "contents sterile unless package is opened or damaged.Do not use if sterile barrier is damaged.If damage is found, call your local distributor or getinge representative.".
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