BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTU CREME TOOTHPASTE

    MDR report key: 5806442 · Received July 19, 2016

    Report

    Report Number
    1314819-2016-00004
    Event Type
    Injury
    Date Received
    July 19, 2016
    Report Date
    October 10, 2014
    Manufacturer
    GLAXOSMITHKLINE LLC
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THIS CASE/REPORT, IT WAS DETERMINED THAT THE INITIAL REPORT THAT WAS SENT CONTAINED THE WRONG MANUFACTURER NUMBER (1020379-2015-00005). THE CORRECT MANUFACTURER NUMBER IS 1314819-2016-00004, AND IT IS ASSOCIATED WITH (B)(4) POLIDENT DENTU CREME TOOTHPASTE.

    Description of Event or Problem · 1

    BLISTERS IN THROAT [OROPHARYNGEAL BLISTERING]. BLISTERS IN MOUTH [BLISTERING OF MOUTH]. BLISTERS ON TONGUE [TONGUE BLISTERING]. THROAT PAIN [THROAT PAIN]. SORES IN MOUTH [SORES MOUTH]. DEVICE MISUSE [DEVICE MISUSE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BLISTERS IN THROAT IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTU CREME TOOTHPASTE) TOOTHPASTE (BATCH NUMBER (B)(4), EXPIRY DATE 30TH SEPTEMBER 2017) FOR DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTU CREME TOOTHPASTE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTU CREME TOOTHPASTE, THE PATIENT EXPERIENCED BLISTERS IN THROAT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BLISTERS IN MOUTH, BLISTERS ON TONGUE, THROAT PAIN AND DEVICE MISUSE. THE PATIENT WAS TREATED WITH SODIUM CHLORIDE (SALT WATER) AND WATER. POLIDENT DENTU CREME TOOTHPASTE WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE BLISTERS IN THROAT, BLISTERS IN MOUTH, BLISTERS ON TONGUE AND THROAT PAIN WERE UNCHANGED AND THE OUTCOME OF THE DEVICE MISUSE WAS RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BLISTERS IN THROAT, BLISTERS IN MOUTH, BLISTERS ON TONGUE AND THROAT PAIN TO BE RELATED TO POLIDENT DENTU CREME TOOTHPASTE. ADDITIONAL DETAILS: THE PATIENT USED POLIDENT DENTU CREME TOOTHPASTE FOR DENTURE ADHESION WHICH REPRESENTS DEVICE MISUSE. THE PATIENT DISCONTINUED USE OF POLIDENT DENTU CREME TOOTHPASTE. THE CONSUMER REPORTED THAT SHE RINSED HER MOUTH WITH SALT WATER AND IT MADE HER CONDITION WORSE SO SHE SWITCHED TO PLAIN WATER AND RINSED HER MOUTH ALL DAY WITH IT. FOLLOW-UP INFORMATION WAS RECEIVED ON 11 FEBRUARY 2015. THE PATIENT RETURNED AN INCOMPLETE AUTHORIZATION TO CONTACT PHYSICIAN FORM ALONG WITH A NOTE. SHE STATED THAT SHE MISTAKENLY USED THE CLEANSER FOR AN ADHESIVE, AND IT WAS IN HER MOUTH ALL NIGHT. SHE STATED THAT SHE WOKE UP WITH SORES IN HER MOUTH AND A SORE THROAT. SHE REPORTED THAT SHE CALLED POISON CONTROL AND THEY SUGGESTED THAT SHE SEE HER DOCTOR, BUT SHE COULDN'T AFFORD TO DO THAT. SHE STATED THAT SHE RINSED HER MOUTH SEVERAL TIMES A DAY FOR A WEEK, AND SHE "HEALED UP FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460399 POLIDENT DENTU CREME TOOTHPASTE DENTURE CLEANSER EFT GLAXOSMITHKLINE LLC 4L22BH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other