BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LD304 MATERNITY BED

    MDR report key: 1916353 · Received November 30, 2010

    Report

    Report Number
    1831750-2010-04285
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    February 16, 2010
    Report Date
    November 1, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: CALF SUPPORT. CONCLUSION: REPLACEMENT CALF SUPPORTS HAVE BEEN ORDERED. THE 3 ALLEGED INCIDENTS; THE NURSES WERE AFFECTED NOT THE PTS. IN THE FIRST 2 OF 3 ALLEGED INCIDENTS, A BACK STRAIN RESULTED. IN THE 3RD ALLEGED INCIDENT, AN ARM/SHOULDER STRAIN RESULTED WHILE THE NURSE TRIED TO GRAB THE STIRRUP BEFORE IT WAS ABLE TO MAKE CONTACT WITH THE MIDWIFE. IN ALL 3 CASES MEDICAL INTERVENTION FOR THE NURSES WAS SOUGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE PERINATAL PERIOPTIC COORDINATOR, THAT THE FACILITY HAS HAD 3 ALLEGED INCIDENTS IN THE PAST 3 MONTH AS A RESULTS OF THE STIRRUPS NOT HOLDING PROPERLY. IN ALL 3 CASES, THE PT'S LEG WAS PUT INTO THE STIRRUP AND AS THE MOTHER BEGAN PUSHING, THE STIRRUP GAVE WAY. IN THE FIRST 2 OF THE 3 ALLEGED INCIDENTS, A BACK STRAIN RESULTED. IN THE 3RD ALLEGED INCIDENT, AN ARM/SHOULDER STRAIN RESULTED WHILE THE NURSE TRIED TO GRAB THE STIRRUP BEFORE IT WAS ABLE TO MAKE CONTACT WITH THE MIDWIFE. IN ALL 3 CASES MEDICAL INTERVENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD304 MATERNITY BED LABOR AND DELIVERY BED HDD STRYKER CORP., MEDICAL DIV. 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK