BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 2031400 · Received February 24, 2011

    Report

    Report Number
    1831750-2011-01837
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE MATTRESS HAS A TORN SURFACE. THE CUSTOMER DOES NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK