BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP DENTURE ADHESIVE

    MDR report key: 20469679 · Received October 17, 2024

    Report

    Report Number
    1000415764-2024-00314
    Event Type
    Injury
    Date Received
    October 17, 2024
    Report Date
    October 14, 2024
    Product Code
    KOO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VEEVA CASE: (B)(4).

    Description of Event or Problem · 0

    I THINK LOOSENS IT UP AND I THINK IT GOES DOWN TO MY THROAT AND SOMETIMES IT MAKES ME CHOKE. [CHOKING]. WHEN DRINKING COFFEE OR SOMETHING LIKE THAT, I THINK LOOSENS IT UP AND I THINK IT GOES DOWN TO MY THROAT [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: ON (B)(6) 2024 A SPONTANEOUS CASE WAS REPORTED IN UNITED STATES OF AMERICA BY A PATIENT VIA CALL CENTER REPRESENTATIVE (PHONE). THE REPORT CONCERNS A CONSUMER. THE CONSUMER RECEIVED POLIGRIP DENTURE ADHESIVE (CARNA+POLMA CREAM) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) FOR INDICATION DENTURE WEARER. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING POLIGRIP DENTURE ADHESIVE, THE CONSUMER EXPERIENCED A MEDICALLY SIGNIFICANT. I THINK LOOSENS IT UP AND I THINK IT GOES DOWN TO MY THROAT AND SOMETIMES IT MAKES ME CHOKE.' (PREFERRED TERM: CHOCKING) THE OUTCOME OF THE CHOCKING WAS UNKNOWN. ON AN UNKNOWN DATE, THE CONSUMER EXPERIENCED A MEDICALLY IMPORTANT CONDITION I THINK LOOSENS IT UP AND I THINK IT GOES DOWN TO MY THROAT, (PREFERRED TERM: ACCIDENTAL DEVICE INGESTION). THE OUTCOME OF THE EVENT ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. THE CONSUMER'S RELEVANT MEDICAL HISTORY INCLUDES: HEART ATTACK (NOT ONGOING), NO DRUG HISTORY WAS REPORTED. TEST RESULT: 2024: X-RAY THROAT: UNKNOWN. THE ACTION(S) TAKEN WERE: FOR POLIGRIP DENTURE ADHESIVE WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE. REPORTER CAUSALITY FOR THE EVENTS WERE NOT REPORTED/ NOT ASSESSABLE FOR ACCIDENTAL DEVICE INGESTION. REPORTER CAUSALITY WAS REPORTED AS REASONABLE POSSIBILITY FOR CHOCKING. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. CASE PRODUCT: POLIGRIP DENTURE ADHESIVE DEVICE MFR NUMBER: 1000415764-2024-00314. THE REPORTER PROVIDED THE FOLLOWING COMMENT: "I USE POLYGRIP FOR MY DENTURES. CAN HAVE ANY EFFECT ON THE LINING OF YOUR THROAT AS IT GETS SWALLOWED? WHEN DRINKING COFFEE OR SOMETHING LIKE THAT, I THINK LOOSENS IT UP AND I THINK IT GOES DOWN TO MY THROAT AND SOMETIMES IT MAKES ME CHOKE. I HAVE 2 STENTS. I HAD A HEART ATTACK. I HAD AN X-RAY DONE ON MY THROAT A COUPLE OF WEEKS AGO AND THEY SAID THEY MIGHT HAVE TO OPERATE MY THROAT BECAUSE THEY SEE SOMETHING, AND I AM TRYING TO FIGURE OUT WHAT IT COULD BE COMING FROM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287065 POLIGRIP DENTURE ADHESIVE DENTURE ADHESIVE KOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other