BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL POWER TB 360

    MDR report key: 13477498 · Received February 8, 2022

    Report

    Report Number
    0002221095-2022-00006
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 15, 2022
    Manufacturer
    COLGATE PALMOLIVE COMPANY
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS IS A SPONTANEOUS REPORT RECEIVED ON 19-JAN-2022 FROM A (B)(6) MALE CONSUMER WHO USED COL POWER TB 360 TOOTHBRUSH AND THE BATTERY ACID LEAKED IN HIS MOUTH, GOT SOME INTO HIS MOUTH AND SWALLOWED SOME, HIS TEETH WERE DISINTEGRATED, AND HAD AN UPSET STOMACH. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON (B)(6) 2022, WHILE THE CONSUMER WAS USING COL POWER TB 360 TOOTHBRUSH (LOT # 2150KE) FOR BRUSHING HIS TEETH THE BATTERY ACID LEAKED OUT OF THE TOOTHBRUSH AND HE GOT SOME INTO HIS MOUTH. CONSUMER REPORTED HE MAY HAVE SWALLOWED SOME OF THE BATTERY ACID AND "HIS TEETH DISINTEGRATED YESTERDAY ((B)(6) 2022), BUT THEY ARE BETTER TODAY". AT THE TIME OF REPORTING, THE CONSUMER STILL HAD AN UPSET STOMACH. ACTION TAKEN WITH THE PRODUCT WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT TEETH WAS DISINTEGRATED WAS RESOLVING, AND THE OUTCOME OF THE EVENT UPSET STOMACH WAS NOT RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 27-JAN-2022, AND THE CASE WAS UPGRADED TO SERIOUS. RELEVANT MEDICAL HISTORY INCLUDED PENICILLIN ALLERGY. ON AN UNSPECIFIED DATE, THE CONSUMER BOUGHT TWO BRAND NEW COL POWER TB 360 TOOTHBRUSHES. CONSUMER BEGAN USING ONE OF THE TOOTHBRUSHES ON (B)(6) 2022. CONSUMER REPORTED AROUND 9PM ON (B)(6) 2022 WHILE USING THE BRUSH THERE WAS AN ELECTRIC SHOCK WHICH HE THOUGHT WAS DUE TO THE TOOTHPASTE. CONSUMER NOTICED THE TOOTHPASTE HAD GOTTEN INTO THE BATTERY COMPARTMENT AND WAS "IN THE SLOTS". THE CONSUMER REPORTED HIS STOMACH, TEETH, THROAT AND TONGUE WERE "ALL MESSED UP". HIS TEETH WERE HURTING AND "BREAKING UP IN LITTLE PIECES". HE ALSO REPORTED HIS THROAT, TONGUE AND STOMACH WERE "REALLY NUMB" AND "I DON'T KNOW LIKE JUST HURTFUL". HE FURTHER DESCRIBED HIS TONGUE "HAS NO FEELING, NOT MUCH". THE CONSUMER REPORTED "SOMETHING HURTING" WITH HIS LUNGS AND WHEN HE BREATHES. CONSUMER FELT A FLUTTERING IN THE RIGHT SIDE OF HIS CHEST AND "CAN'T GET MY BREATH IN". CONSUMER ALSO EXPERIENCED URINE AND STOOL "BURNING REAL BAD" AND HE WAS TOO SICK TO DO ANYTHING. CONSUMER REPORTED HE DID NOT GO TO THE EMERGENCY ROOM, BUT HE DID SPEAK TO POISON CONTROL. THE CONSUMER DID NOT USE THE TOOTHBRUSH AGAIN AFTER (B)(6) 2022 USE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT TEETH WAS DISINTEGRATED WAS RESOLVING, AND THE OUTCOME OF THE OTHER EVENTS WERE NOT RESOLVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 15MAR2022. THE CONSUMER'S WEIGHT WAS REPORTED AS 195 POUNDS AND THE DATE OF BIRTH OF THE CONSUMER WAS ADDED. CONSUMER REPORTED HE OPENED AND USED THE COL POWER TB 360 TOOTHBRUSH THE NIGHT OF (B)(6) 2022 AND FELT A SHOCK IN HIS MOUTH. THE CONSUMER NOTICED THAT TOOTHPASTE WAS IN THE SLOT ON THE BACK OF THE HEAD AND THE SLOTS ALL THE WAY DOWN TO THE BATTERY COMPARTMENT. CONSUMER OPENED THE BATTERY COMPARTMENT AND SAW TOOTHPASTE FOAMING AND BUBBLING UP IN IT AND STARTED RINSING HIS MOUTH OUT FOR 10 MINUTES. THE CONSUMER REPORTED HE WAS STILL SICK AND HIS TEETH WERE CRUMBLING TO PIECES. HE ALSO REPORTED, "MY TOOTH AND CHEST AND BODY IS DISFORMED". THE CONSUMER ONLY USED COL POWER TB 360 TOOTHBRUSH ONE TIME. AT THE TIME OF REPORTING, THE CONSUMER HAD NOT RECEIVED ANY TREATMENT FOR THE EVENTS EXPERIENCED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT TEETH WAS DISINTEGRATED WAS RESOLVING, AND THE OUTCOME OF THE OTHER EVENTS WERE NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757323 COL POWER TB 360 COL POWER TB 360 EFW 2150KE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other| C