BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECARECOMPANION

    MDR report key: 9728684 · Received February 19, 2020

    Report

    Report Number
    1125873-2020-00002
    Event Type
    Injury
    Date Received
    February 19, 2020
    Report Date
    January 30, 2020
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DRG
    UDI-DI
    00884838084452
    PMA / PMN Number
    K043217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A SKIN TEAR OCCURRED WHILE USING THE DEVICE, WHICH REQUIRED MEDICAL INTERVENTION AND/OR ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192170 ECARECOMPANION ECAD BP MEDIUM/LG DRG VISICU, INC - DUP 453564551731 NA 00884838084452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other