BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION)

    MDR report key: 4051827 · Received August 8, 2014

    Report

    Report Number
    1718912-2014-00014
    Event Type
    Other
    Date Received
    August 8, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 6, 2014
    Manufacturer
    GLAZOSMITHKLINE
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS (B)(4). BIOTENE DRY MOUTH ORAL RINSE IS MANUFACTURED IN (B)(4). THE PRODUCT LOT NUMBER 3D27C1. THE PRODUCT HAS NOT BEEN RETURNED (NOT AVAILABLE). (B)(4). ADVERSE EVENT TERM(S): DEAFNESS UNILATERAL, HYPERSENSITIVITY, SWELLING FACE, LIP SWELLING, OROPHARYNGEAL DISCOMFORT, DRUG INTERACTION, DEVICE MISUSE.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNILATERAL DEAFNESS IN A (B)(6) YEAR-OLD FEMALE PT WHO RECEIVED ORAL MOISTURISERS (BIOTENE DRY MOUTH ORAL RINSE (213 FORMULATION) MOUTHWASH FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. ON AN UNK DATE, THE PT STARTED ORAL MOISTURISERS (DENTAL). ON (B)(6) 2014, THE PT EXPERIENCED UNILATERAL DEAFNESS, ALLERGIC REACTION, SWELLING OF FACE, LIP SWELLING, STRANGE FEELING IN THROAT, POSSIBLE DRUG INTERACTION AND DEVICE MISUSE. THE PT STATED THAT SHE FEELS SHE HAD A DRUG INTERACTION WHILE USING FIXODENT AND BIOTENE ORAL RINSE TOGETHER. SHE STATED THAT SHE POURED BIOTENE ORAL RINSE INTO AN EMPTY BOTTLE OF BIOTENE MOUTH SPRAY AND USED IT AS A SPRAY (DEVICE MISUSE). SHE STATED THAT HER EAR FELT LIKE IT WAS GOING DEAF. SHE REPORTED THAT WHEN SHE WENT TO THE EMERGENCY ROOM, SHE WAS TREATED WITH STEROIDS OF SOME KIND, PEPCID, AND A THIRD UNK MEDICATION. SHE REPORTED THAT SHE DID NOT NEED TO BE HOSPITALIZED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PT WAS TREATED WITH STEROID (STEROIDS), FAMOTIDINE (PEPCID), SALBUTAMOL SULPHATE (ALBUTEROL), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) AND UNK. TREATMENT WITH ORAL MOISTURISERS WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS HAD RESOLVED, THE OUTCOME OF DEVICE MISUSE WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472883 BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) ORAL MOISTURISERS LFD GLAZOSMITHKLINE N/A 3D27C1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other UNSPECIFIED MEDICATION (UNK - UNK)