BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH PROCLEAN

    MDR report key: 3830777 · Received May 1, 2014

    Report

    Report Number
    2280705-2014-00020
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    May 1, 2014
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: CAPA# (B)(4). ADDRESSES THIS COMPLAINT TYPE (REAR HOUSING BREAKAGE OF BRUSH HEAD). CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AS OF Q3 2013 TO REDUCE THE OCCURRENCE OF REAR HOUSING BREAKAGE. BASED ON THE HEAD LOT CODE (DD3337H3), THIS PRODUCT WAS MANUFACTURED AFTER IMPLEMENTATION OF CORRECTIVE ACTIONS. CURRENTLY, TWO COMPLAINTS OF REAR HOUSING BREAKAGE WITH POST-CAPA LOT CODES HAVE BEEN REC'D. QUALITY WILL CONTINUE TO MONITOR THESE COMPLAINTS.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE. THIS IS REPORTED AS MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261184 ARM & HAMMER SPINBRUSH PROCLEAN TOOTHBRUSH, POWERED JEQ DD3337H3

    Patients

    Seq Age Sex Outcome Treatment
    1