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Model Number 71174921 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that upon inspection the box label code was mistaken.The instruments inside the box were different, the actual products inside were 71174821, with batch lot 18mup0006.There was no case involved.The event was an out of the box failure.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states the failure was found during inspection and there are no previous serious events for this malfunction, 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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Manufacturer Narrative
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After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that upon inspection the box label code was mistaken.The instruments inside the box were different, the actual products inside were 71174821, with batch lot 18mup0006.There was no case involved.The event was an out of the box failure.However after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable.
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Search Alerts/Recalls
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