Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Itching Sensation (1943)
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Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2018-00104 and 3012447612-2018-00111 thru 3012447612-2018-00119.
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Event Description
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It was reported that a patient is experiencing an itching sensation after having a polaris 4.75 construct installed.Additional information has been requested but has not been made available.This is report six of ten for this event.
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Manufacturer Narrative
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Follow-up with the reporter revealed the patient is doing fine and the family has no plans to remove the construct since the itching sensation does not bother the patient often or significantly.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Search Alerts/Recalls
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