BEUDAMED
    FDA Adverse Event Summary report: N

    COLGATE TWISTER TOOTHBRUSH SOFT

    MDR report key: 2842493 · Received November 13, 2012

    Report

    Report Number
    3003205012-2012-00008
    Date Received
    November 13, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 18, 2012
    Manufacturer
    COLGATE SANXIAO CO., LTD.
    Product Code
    EFW
    PMA / PMN Number
    872.6855
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL INFO WAS RECEIVED ON (B)(6) 2012 FROM A CONSUMER. THIS (B)(6) FEMALE CONSUMER USED COLGATE TWISTER TOOTHBRUSH SOFT (LOT# 060411BR1038) AND DEVELOPED THROAT IRRITATION, PAIN AND DISCOMFORT AFTER A BRISTLE BECAME STUCK IN HER THROAT. SHE BEGAN USING THE TOOTHBRUSH ON (B)(6) 2012, BRUSHING THREE TO FIVE TIMES DAILY. ON (B)(6) 2012, SHE SUBSEQUENTLY EXPERIENCED THE EVENTS. SHE DISCONTINUED USE OF THE TOOTHBRUSH ON (B)(6) 2012. ON (B)(6) 2012, SHE WAS ADMITTED TO A CLINIC AND A LARYNGOSCOPY EXAM WAS PERFORMED AND THE ATTENDING PHYSICIAN INDICATED SURGERY WAS NECESSARY TO REMOVE THE BRISTLE STUCK IN HER THROAT. THE PHYSICIAN DID NOT WANT TO REMOVE THE BRISTLE WITH TWEEZERS DUE TO THE RISK OF BLEEDING. SHE WAS ADMITTED TO THE CLINIC FOR 5 HOURS, GIVEN INTRAVENOUS ANESTHESIA AND AN ORAL ANALGESIC. AT THE TIME OF THIS REPORT, THE CONSUMER HAD RECOVERED. THIS CASE HAS BEEN ASSESSED AS FOLLOWS: BRISTLE STUCK IN THROAT (FOREIGN BODY) - UNEXPECTED, THROAT IRRITATION (THROAT IRRITATION() - UNEXPECTED, AND THROAT DISCOMFORT AND PAIN (THROAT PAIN) - UNEXPECTED. THIS ASSESSMENT IS BASED ON INITIAL INFO RECEIVED ON (B)(6) 2012 AND IS DUE TO THE NATURE AND COMBINATION OF EVENTS PRESENTED THROUGHOUT THE CASE. MAH COMMENT: THE CASE REPORTS INSUFFICIENT INFO WITH REGARDS TO THE PT MEDICAL HISTORY, CONCURRENT ILLNESS OR CONCOMITANT MEDICATIONS. HOWEVER, BASED ON A TEMPORAL RELATIONSHIP OF THE EVENTS WITH THE USE OF THE PRODUCT ALONG, WITH THE PT'S RECOVERY POST MEDICAL INTERVENTION THE POTENTIAL FOR A DRUG EVENT CAUSAL ASSOCIATION SEEMS POSSIBLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLGATE TWISTER TOOTHBRUSH SOFT MANUAL TOOTHBRUSH EFW COLGATE SANXIAO CO., LTD. 060411BR1038

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R