BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CARE SENSOR PAD

    MDR report key: 1372252 · Received April 24, 2009

    Report

    Report Number
    MW5010921
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    March 10, 2009
    Report Date
    April 24, 2009
    Manufacturer
    SMART CAREGIVER CORP
    Product Code
    OHN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SENSOR PAD KEPT MALFUNCTIONING - KEPT SOUNDING WHEN RESIDENT WAS NOT MOVING. RESIDENT ENDED UP FALLING RESULTING IN RIB FRACTURE AND ABRASION TO SCAPULA. SENSOR PAD # SMART CARE 90 DAY WARRANTY MONITOR FOR CHAIR / BED #TL-04 SMART CAREGIVER CORP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CARE SENSOR PAD SENSOR PAD ALARM OHN SMART CAREGIVER CORP TL-04

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR