Model Number MBUR4060FRCV |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The devices were not returned for evaluation.The cause of the reported event cannot be determined at this time.
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Event Description
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The service center was informed that during preparation to use, it was noted that the labeling on the device packaging did not match the product inside.The packaging was not bent, dented or torn.It was reported that the customer ordered mastoid cutting burrs but received diamond burrs.There was no patient involvement and therefore no patient injury was reported.This is 6 of 7 reports.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.Dhr review was performed.Dhr for the finished device was reviewed and no abnormalities in documentation or process was found.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information received.Please see the updates in sections: g4, g7, h2 and h10.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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