BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ RECHARGE POWERED TOOTHBRUSH

    MDR report key: 2974434 · Received February 22, 2013

    Report

    Report Number
    2280705-2013-00014
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED BETWEEN (B)(6) 2013. LOT CODES: HEAD DF1260F1, HANDLE DF1291A1, CHARGER DF1283G2. THE HEAD WAS MANUFACTURED AT ONE OF THE FOLLOWING LOCATIONS. CONTRACT MANUFACTURER: HAYCO LTD. (B)(4); CONTRACT MANUFACTURER: SHANTOU CITY KIN SENG PLASTIC CO., LTD. (B)(4). THE HANDLE AND CHARGER WERE MANUFACTURED AT THE FOLLOWING LOCATION. CONTRACT MANUFACTURER: SHANTOU CITY KIN SENG PLASTIC CO., LTD. (B)(4). DEVICE MANUFACTURE DATES: HEAD 9/17/2011, HANDLE 10/18/2011, CHARGER 10/10/2011.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78960 SPINBRUSH¿ PROCLEAN¿ RECHARGE POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00160

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR