BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRAYOLA PIPSQUEAK TOOTHBRUSH

    MDR report key: 5591436 · Received April 20, 2016

    Report

    Report Number
    0001413787-2016-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 18, 2016
    Report Date
    June 6, 2016
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    SUNSTAR WILL CONTINUE TO CONTACT THE COMPLAINANT FOR FURTHER DETAILS AND FOLLOW-UP REGARDING THE CHILD SPECIALIST RECOMMENDATION. (B)(4).

    Description of Event or Problem · 1

    GRANDMOTHER OF A CHILD REPORTED TO SUNSTAR AMERICAS, INC. (SUNSTAR) THAT HER GRANDDAUGHTER WAS USING THE CRAYOLA 232 PIPSQUEAK TOOTH BRUSH AND BRISTLES FELL OUT AND LODGED IN HER THROAT. LODGED BRISTLES CAUSED GAG REFLEX AND CHILD VOMITED SEVERAL TIMES DUE TO GAG. THE CHILD WAS TAKEN TO THE HOSPITAL (EMERGENCY ROOM) AND WAS TREATED WITH ANTI-NAUSEA MEDICATION TO ALLEVIATE VOMITING. BRISTLES WERE EVENTUALLY DISLODGED AND CHILD STARTED FEELING BETTER, WAS ABLE TO DRINK AND EAT. THE CHILD WAS DISCHARGED FROM HOSPITAL ON THE SAME DAY AND REFERRED TO A THROAT SPECIALIST FOR A FOLLOW-UP. ON (B)(4) 2016 SUNSTAR CONTACTED THE CHILD'S GRANDMOTHER AND WAS PROVIDED WITH CONTACT NUMBER OF CHILD'S MOTHER. CHILD'S MOTHER WAS CONTACTED ON SAME DAY AND A MESSAGE WAS LEFT ON THE SAME DAY. SUNSTAR AGAIN CONTACTED CHILD'S MOTHER ON (B)(4) 2016 AND THE MOTHER CONFIRMED THE CHILD IS FINE NOW. CHILD'S MOTHER INDICATED THAT SHE IS UNCERTAIN WHETHER SHE WILL TAKE THE CHILD TO THE SPECIALIST FOR A FOLLOW-UP. SUNSTAR REQUESTED A CALL BACK FROM CHILD'S MOTHER ONCE THE SPECIALIST HAS BEEN SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247561 CRAYOLA PIPSQUEAK TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS, INC. 232RG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Other