BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2141 STANDARD MODEL 1

    MDR report key: 2920506 · Received January 17, 2013

    Report

    Report Number
    0001831750-2013-00170
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE DISCOVERY DURING THE INVESTIGATION PROCESS THAT THIS ISSUE HAD BEEN REPORTED ON MEDWATCH 1831750-2013-90501. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTERS NEEDED TO BE REPLACED.A SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE DISCOVERY DURING THE INVESTIGATION PROCESS THAT THIS ISSUE HAD BEEN REPORTED ON MEDWATCH 1831750-2013-90501 (INTERNALLY PER 366006). PLEASE REFER TO THESE REPORTS FOR THE INVESTIGATION AND REGULATORY ASSESSMENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTERS NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25732 2141 STANDARD MODEL 1 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1