BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 2910286 · Received December 19, 2012

    Report

    Report Number
    1831750-2012-13078
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE MECHANISM IS BENT AND THE FOOT REST WILL NOT CLOSE CORRECTLY AND STAY LATCHED. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREATMENT RECLINER RECLINER FRK STRYKER MEDICAL 3500000710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1