BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXI MOVE

    MDR report key: 1884185 · Received October 21, 2010

    Report

    Report Number
    9681684-2010-00043
    Event Type
    Other
    Date Received
    October 21, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    DURING RESIDENT DIAPER CHANGE, THE CAREGIVER NOTICED A CUT ON RESIDENT'S GENITALS. THE FACILITY SUSPECTED THAT THE INJURY MAY HAVE OCCURRED 4 HOURS BEFORE DUE TO A SLING PINCHING THE GENITAL AREA DURING A TRANSFER FROM BED TO CHAIR, BUT COULD NOT CONFIRM THIS. THE RESIDENT SUSTAINED A 4.5 CM SKIN TEAR WITH MINIMAL BLEEDING. IT WAS REPORTED THAT THE PT WENT TO THE HOSPITAL FOR TREATMENT, HOWEVER NO FURTHER INFO WAS RELEASED TO ARJOHUNTLEIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PATIENT, LIFT, NON-AC POWERED FSA BHM MEDICAL, INC. KMCSUN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O