BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRAM

    MDR report key: 1210903 · Received October 22, 2008

    Report

    Report Number
    MW5008736
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 30, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ALCOHOL MONITORING SERVICES-AMS
    Product Code
    OIC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    I WORE A SCRAM ALCOHOL MONITORING BRACELET. THE MFR OF THE DEVICE IS AMS-ALCOHOL MONITORING SERVICES. WHEN I WAS WEARING THE DEVICE, I DEVELOPED SEVERE BONE AND JOINT PAIN. I WENT TO A RHEUMATOLOGIST AND HE DID A BONE SCAN SHOWING ABNORMALITIES IN ALL MY JOINTS. WITHIN A MONTH OF REMOVING THE DEVICE, THE PAIN SUBSIDED. I HAVE NOT HAD ANOTHER BONE SCAN TO SEE IF THERE HAS BEEN ANY CHANGE IN THE BONE SCAN. SCRAM DEVICE WAS WORN FOR 90 DAYS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: ALCOHOL ISSUES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRAM SCRAM OIC ALCOHOL MONITORING SERVICES-AMS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other