BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLGATE TOTAL MINT FLOSS

    MDR report key: 2818457 · Received December 7, 2009

    Report

    Report Number
    9613415-2009-00001
    Event Type
    Other
    Date Received
    December 7, 2009
    Date of Event
    October 21, 2009
    Report Date
    November 20, 2009
    Manufacturer
    COLGATE-PALMOLIVE
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - DEVICE WAS REQUESTED, BUT NOT YET RETURNED AT THE TIME OF THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED ON (B)(6) 2009 FROM A CONSUMER WHO IS ALSO A NURSE. THIS (B)(6) FEMALE REPORTED THAT ON (B)(6) 2009, SHE TOOK HER GRANDDAUGHTER'S AMOXICILLIN 500 MG CHEWABLE TABLET AND WENT TO HER DENTIST ON (B)(6) 2009 FOR A DEEP GUM CLEANING. THAT NIGHT ((B)(6) 2009), SHE TOOK ANOTHER DOSE OF THE AMOXICILLIN 500 MG AND SHE FLOSSED HER TEETH WITH COLGATE MINT FLOSS THAT SHE HAD RECEIVED FROM HER DENTIST. SHE HAD ALSO RECEIVED A COLGATE 360 TOOTHBRUSH FROM THE DENTIST THAT SAME DAY. SOON AFTER TAKING THE AMOXICILLIN 500 MG AND FLOSSING HER TEETH, SHE BEGAN NOT FEELING WELL. SHE STARTED SHAKING, HAD TREMORS, RIGOR, WAS VERY COLD, HER HEART WAS BEATING FAST, HER FACE BECAME RED, SHE WAS SHORT OF BREATH AND SHE COULD NOT CATCH HER BREATH. SHE DID NOT KNOW IF SHE HAD USED THE TOOTHBRUSH PRIOR TO HER REACTION. SHE TOOK A (B)(4) (LORATADINE) (AMOUNT AND DOSE UNK) AND ALBUTEROL SPRAY (AMOUNT AND DOSE UNK) AT HOME. SHE WAS NOT GETTING BETTER SO SHE WENT TO THE HOSPITAL EMERGENCY ROOM. AT THE EMERGENCY ROOM, HER BLOOD PRESSURE WAS 90/40, HER OXYGEN SATURATION WAS 72 TO 74 AND HER ENTIRE BODY WAS RED. SHE WAS TREATED WITH (B)(4) (DEXAMETHASONE) 24 MG INTRAVENOUS (IV), (B)(4) (FAMOTIDINE) IV (DOSAGE UNK), 2 ALBUTEROL NEBULIZER TREATMENTS (DOSAGE UNK) CONSECUTIVELY, AND (B)(4) (DIPHENHYDRAMINE) 50 MG IV. THE ELECTROCARDIOGRAM (EKG) WAS NORMAL, AND BLOOD WORK WAS DRAWN (TYPES OF BLOOD WORK AND RESULTS UNK). SHE WAS RELEASED TO GO HOME THE SAME NIGHT ((B)(6) 2009) 3 HOURS AFTER SHE ARRIVED AT THE EMERGENCY ROOM. SHE WAS STILL A LITTLE SHAKY AND THE REDNESS TO HER BODY WAS ALMOST GONE WHEN SHE LEFT THE EMERGENCY ROOM. SHE WAS GIVEN PREDNISONE (DOSAGE AND FREQUENCY UNK) TO TAKE FOR A FEW DAYS. AT THE TIME OF THIS REPORT, SHE FELT FINE AND HAD IMPROVED COMPLETELY. SHE HAD NO MEDICAL F/U SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLGATE TOTAL MINT FLOSS DENTAL FLOSS JES COLGATE-PALMOLIVE NI 9313B

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other PROCARDIA (NIFEDIPINE): 60 MG ONCE A DAY FOR MANY| LISINOPRIL: 20MG ONE A DAY| YEARS (EXACT DATES UNK)