BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 26 OBS 10/04

    MDR report key: 3002834 · Received March 13, 2013

    Report

    Report Number
    0001831750-2013-01991
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WILL BE SENT A REPLACEMENT.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE OF MFR REPORT # 1831750-2012-12924. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1001000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 1831750-2012-12924 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1001000000 FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL WOULD NOT LATCH DUE TO A WELD BREAK AND EXPOSED SHARP EDGES WERE REPORTED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MFR REPORT # 1831750-2012-12924. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1001000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 1831750-2012-12924 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1001000000 FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105155 ADVANTAGE SERIES 26 OBS 10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 1001

    Patients

    Seq Age Sex Outcome Treatment
    1