BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM® SOFT-PICK® ORIGINAL

    MDR report key: 20192359 · Received September 11, 2024

    Report

    Report Number
    1413787-2024-00142
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SUNSTAR AMERICAS, INC
    Product Code
    JET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE IS MADE TO (B)(4) UNDER REPORT# (B)(4) SUBMITTED AS A 30 DAY MDR ON (B)(6) 2024 BY SUNSTAR AMERICAS INC (SAI). (B)(6) WOULD LIKE TO NOTIFY THE AGENCY THAT WE BECAME AWARE THAT THIS REPORTED SERIOUS ADVERSE EVENT WAS NOT CONFIRMED TO BE A GUM BRAND PRODUCT. ON (B)(6) 2024, WE RECEIVED A PICTURE OF THE DEVICE FROM THE CUSTOMER. UPON EXAMINATION, IT WAS DETERMINED THAT IT IS NOT A PRODUCT DESIGN SAI HAS EVER PRODUCED OR SOLD.

    Description of Event or Problem · 0

    CONSUMER USED SOFT PICK IN HER MOUTH AND THE GREEN TIP CAME OFF OF THE PICK CAUSING HER TO SWALLOW. SHE CALLED THE HOSPITAL HOTLINE AND A NURSE INSTRUCTED HER TO IMMEDIATELY COME IN. SHE WAS GIVEN A LIQUID NUMBING MEDICINE TO COAT HER THROAT. THEY KEPT HER IN THE ER FOR A COUPLE OF HOURS AFTER DOING X-RAYS. THEY DID NOT PRESCRIBE HER ANY MEDICATION TO GO HOME WITH. UPDATED INFORMATION WHEN SHE WAS CALLED BACK, SHE SAID AFTER THE XRAY THE DOCTORS DID NOT SEE ANYTHING AND RELEASED HER. SHE DOES NOT FEEL ANYTHING IN HER THROAT; HOWEVER, SHE IS STILL HOARSE.

    Description of Event or Problem · 0

    CUSTOMER USED SOFT PICKS ORIGINAL, FORCED SOFT PICK IN HER MOUTH AND THE GREEN TIP CAME OFF OF THE SOFT PICK CAUSING HER TO SWALLOW IT. SHE CALLED THE HOSPITAL HOTLINE AND A NURSE INSTRUCTED HER TO IMMEDIATELY COME IN. THEY GAVE HER A LIQUID NUMBING MEDICINE TO COAT HER THROAT. THEY KEPT HER IN THE ER FOR A COUPLE OF HOURS AFTER DOING X-RAYS. THEY DID NOT PRESCRIBE HER ANY MEDICATION TO GO HOME WITH. UPDATED INFORMATION WHEN SHE WAS CALLED BACK: SHE SAID AFTER THE XRAY THE DOCTORS DID NOT SEE ANYTHING AND RELEASED HER. SHE DOES NOT FEEL ANYTHING IN HER THROAT; HOWEVER, SHE IS STILL HOARSE. SHE HAD A FOLLOW UP APPOINTMENT ON (B)(6) 2024 WITH DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474966 GUM® SOFT-PICK® ORIGINAL PICK, MASSAGING JET SUNSTAR AMERICAS, INC 6323R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown