BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK (NOT APPLICABLE) TOOTHBRUSH 1APPLIC

    MDR report key: 1651942 · Received June 14, 2010

    Report

    Report Number
    1530449-2010-00008
    Event Type
    Other
    Date Received
    June 14, 2010
    Date of Event
    April 1, 2010
    Report Date
    May 31, 2010
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH BATCH TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    COMPLETE LOSS OF SIGHT IN ONE EYE [BLINDNESS UNILATERAL]. CHILD PIERCED EYE WHEN SLIPPED AND FELL ON METAL SHAFT OF ORAL-B POWER TOOTHBRUSH [EYE INJURY]. CASE DESCRIPTION: A CONSUMER REPORTED THAT HIS (B)(6) SON WAS CHANGING THE BRUSHHEAD ON HIS ORAL-B RECHARGEABLE, VERSION UNK TOOTHBRUSH IN (B)(6) 2010, WHEN HE SLIPPED AND FELL ON THE METAL SHAFT OF THE POWER TOOTHBRUSH; THE SHAFT PIERCED HIS EYE AND RESULTED IN A COMPLETE LOSS OF SIGHT IN ONE EYE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNK (NOT APPLICABLE) TOOTHBRUSH 1APPLIC NONE JEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other| S