BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 10310969 · Received July 22, 2020

    Report

    Report Number
    0001831750-2020-00719
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    April 1, 2020
    Report Date
    July 22, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    NZG
    UDI-DI
    07613327261615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WAS A BENT COMPONENT. THE DEVICE WAS REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE HAD ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775463 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 4402 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1