BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2500MS & M2500-39 LALAPM

    MDR report key: 3005099 · Received March 14, 2013

    Report

    Report Number
    0001831750-2013-02030
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INDICATE THAT THE ACCOUNT DID NOT IDENTIFY THE UNIT INVOLVED IN THE ALLEGED INCIDENT, AND THEREFORE, THE UNIT WAS NOT EVALUATED BY THE MANUFACTURER. IT WAS CONFIRMED WITH THE ACCOUNT THAT NO ADDITIONAL INFORMATION WAS AVAILABLE AND THAT NOTHING WAS NEEDED FROM THE MANUFACTURER. UNIT WAS NOT IDENTIFIED OR MADE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATTRESS WAS LOOSING AIR AND A PATIENT ALLEGEDLY INCURRED RED SPOTS ON THEIR BUTTOCKS AREA. THE CUSTOMER ALLEGED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATTRESS WAS LOOSING AIR AND A PATIENT ALLEGEDLY INCURRED RED SPOTS ON THEIR BUTTOCKS AREA. THE CUSTOMER ALLEGED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107835 C2500MS & M2500-39 LALAPM BED, FLOTATION THERAPY, POWERED IOQ STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other