BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION

    MDR report key: 10928139 · Received December 1, 2020

    Report

    Report Number
    3012293198-2020-00106
    Event Type
    Injury
    Date Received
    December 1, 2020
    Report Date
    November 17, 2020
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MY GRANDSON, JUST HAD A SIP OF THE BIOTENE GENTEL MINT ORAL RISE. 16OZ [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2020, THE PATIENT STARTED BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION RECEIVED VIA CALL CENTER REPRESENTATIVE ON (B)(6) 2020. THE CONSUMER REPORTED, "MY GRANDSON, JUST HAD A SIP OF THE BIOTENE GENTLE MINT ORAL RISE. 16OZ, IS HE GOING TO BE OKAY? FOLLOW UP INFORMATION WAS RECEIVED ON 24 NOVEMBER 2020. THE CONSUMER STATED THAT HER GRANDSON WAS FINE, HE DID NOT HAVE ANY SYMPTOMS AND DID NOT WANT TO PERFORM FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391579 BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION ORAL RINSES LFD KIK CUSTOM PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other