Brief: FDA Says Death Reported In MDR Described Malfunctioning Cerelink ICP Monitor During Use In Critically Injured Patient & Was Mitigated By Replacing ICP Sensor

Integra LifeSciences Holdings

01/09/2022 20:48

Sept 1 (Reuters) - FDA:
    * FDA -DEATH REPORTED IN MDR DESCRIBED MALFUNCTIONING
CERELINK ICP
MONITOR DURING USE IN CRITICALLY INJURED PATIENT & WAS MITIGATED
BY REPLACING ICP SENSOR
    * FDA - CAUSE OF PATIENT DEATH WAS DETERMINED BY INTEGRA TO
BE
UNRELATED TO THE CERELINK ICP MONITOR MALFUNCTION

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 ((Reuters.Briefs@thomsonreuters.com;))