BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMEMER SPINBRUSH PROWHITENING

    MDR report key: 3955807 · Received June 5, 2014

    Report

    Report Number
    2280705-2014-00024
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    June 5, 2014
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, WE ARE UNABLE TO DETERMINE WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MANUFACTURED. HEADS AND BODIES ARE MANUFACTURED AT THE FOLLOWING LOCATION: (B)(4).

    Description of Event or Problem · 1

    CONSUMER FROM (B)(6) REPORTED TO CHURCH AND DWIGHT CO., INC. (B)(4) THAT "LOWER BRISTLE PLATE FELL OFF BRUSH HEAD." BRUSH USED LONGER (OVER 3 MONTHS) THAN USE INSTRUCTION DICTATE (3 MONTHS). NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329857 ARM & HAMEMER SPINBRUSH PROWHITENING TOOTHBRUSH, POWERED JEQ DF1260F1

    Patients

    Seq Age Sex Outcome Treatment
    1