BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL-B ADVANCEPOWER 450TX BRIGHT TOOTHBRUSH

    MDR report key: 2191890 · Received May 13, 2008

    Report

    Report Number
    3000302531-2008-00001
    Event Type
    Other
    Date Received
    May 13, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT BATCH LOT INFORMATION WAS NOT PROVIDED FROM THE INITIAL REPORTER. PRODUCT REQUESTED FROM CONSUMER BUT NOT RECEIVED TO DATE; THEREFORE; UNABLE TO PROCEED WITH DEVICE EVALUATION.

    Description of Event or Problem · 1

    CUT IN EYE FROM PLASTIC [EYE PENETRATION]. CUT ON HAND [SKIN LACERATION]. PLASTIC HIT HEAD [HEAD INJURY]. PIECE OF TOOTHBRUSH IN EYE [FOREIGN BODY IN EYE]. DEVICE BREAKAGE (ENTIRE TOOTHBRUSH IN PIECES) [DEVICE BREAKAGE]. SORENESS IN EYE [EYE PAIN]. VISION BLURRY [VISION BLURRED]. FACE BRUISED [CONTUSION]. IRRITATION EYE [EYE IRRITATION]. HEADACHES [HEADACHE]. PAIN [PAIN]. HEAD SWELLING [LOCAL SWELLING]. HIT ME IN THE CHEEK-FACE [FACE INJURY]. (HAND IS CUT) THAT IS WHERE THE BLEEDING IS COMING FROM [HAEMORRHAGE]. HIT ME IN THE EYE [EYE INJURY]. CASE DESCRIPTION: A CONSUMER REPORTED THAT HIS WIFE, AGE UNSPECIFIED, USED AN ORAL-B POWER TOOTHBRUSH, VERSION UNKNOWN FOR THE PAST 6 TO 8 MONTHS. THE TOOTHBRUSH BATTERIES HAD BEEN RECENTLY CHANGED, AND ON (B)(6) 2008, "THE ENTIRE BOTTOM OF THE TOOTHBRUSH BLEW APART, AND THE TOOTHBRUSH WAS SPLIT END TO END". HE REPORTED HIS WIFE SUSTAINED MULTIPLE INJURIES WHEN THE TOOTHBRUSH BLEW UP. INJURIES INCLUDED A CUT ON HER HAND, SWELLING OF HER HEAD FROM TOOTHBRUSH DEBRIS, AND REMOVAL OF A PLASTIC PIECE IN THE EYE. THE CASE OUTCOME WAS NOT RECOVERED/RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - UNKNOWN, MEDICAL HISTORY - "CANCER". CONCOMITANT MEDICATIONS INCLUDED: "BLOOD THINNERS" AND UNSPECIFIED CANCER DRUGS. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2008, DRUG AND POISON INFORMATION CENTER FOLLOW-UP PHONE CALL WITH THE CONSUMER AND THE CONSUMER'S WIFE: THE CONSUMER'S WIFE REPORTED THAT SHE WAS SEEN AT AN URGENT CARE CENTER ON (B)(6) 2008. SHE WAS DIAGNOSED WITH A CUT IN HER EYE. ADDITIONAL SYMPTOMS REPORTED INCLUDE SORENESS IN HER EYE AND BLURRY VISION. TREATMENT CONSISTED OF UNSPECIFIED EYE DROPS, UNSPECIFIED ORAL ANTIBIOTICS AND UNSPECIFIED PAIN MEDICATION. THE CONSUMER'S WIFE WILL BE FOLLOWING UP WITH HER PHYSICIAN WHO ALSO WANTED HER TO SEE AN EYE SPECIALIST. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2008, CONSUMER RELATIONS FOLLOW-UP PHONE CALL: THE CONSUMER REPORTED ADDITIONAL SYMPTOMS OF EYE IRRITATION, BRUISED FACE, HEADACHES, AND PAIN, AFTER THE TOOTHBRUSH BLEW UP IN HIS WIFE'S HAND. THE SYMPTOMS HAVE NOT IMPROVED. HIS WIFE WILL BE FOLLOWING UP WITH HER PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2008, SAFETY SURVEILLANCE'S FOLLOW-UP PHONE CALL TO THE CONSUMER: THE CONSUMER REPORTED THAT URGENT CARE COMPLETED AN UNSPECIFIED DIAGNOSTIC TEST OF AN EYE SOLUTION WITH A BLACK LIGHT, TO SEE IF THERE WAS ANYTHING IN LEFT IN HIS WIFE'S EYE ON (B)(6) 2008. THE TEST CONCLUDED THAT ALL FOREIGN OBJECTS HAD BEEN SUCCESSFULLY REMOVED FROM HER EYE. THE URGENT CARE PHYSICIAN PRESCRIBED AN ANTIBIOTIC CREAM IN HER EYE AND THAT SHE WAS NOW TAKING AMOXICILLIN AND LORTAB FOR TREATMENT. THE HUSBAND REPORTED THAT HE TOOK HIS WIFE TO SEE HER PHYSICIAN ON (B)(6) 2008. HE REPORTED THAT SHE WAS STILL HAVING SOME EYE IRRITATION AND HEADACHES, AND THAT HE WAS TAKING HER FOR X-RAYS ON THE SIDE OF THE FACE WHERE THE PLASTIC PIECES HIT HER. THE SWELLING ON THE SIDE OF HER FACE WAS IMPROVING. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2008 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT OF (B)(6) 2008: A CONSUMER REPORTED HIS WIFE USED AN ORAL-B POWER TOOTHBRUSH, VERSION UNKNOWN ONCE TO TWICE DAILY FOR THE PAST 6 TO 8 MONTHS WHEN IT BLEW APART IN HER HAND ON (B)(6) 2008. SHE HAD BLOOD COMING FROM A CUT ON HER HAND. THE TOOTHBRUSH DEBRIS HIT HER IN THE CHEEK AND THE EYE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL-B ADVANCEPOWER 450TX BRIGHT TOOTHBRUSH POWERED TOOTHBRUSH JEQ BRAUN GMBH WERK MARKTHEIDENFELD 450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention