BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1

    MDR report key: 20597053 · Received November 4, 2024

    Report

    Report Number
    1314819-2024-00115
    Event Type
    Injury
    Date Received
    November 4, 2024
    Report Date
    October 25, 2024
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VEEVA CASE: (B)(4).

    Description of Event or Problem · 0

    MY EYES ALWAYS BURN, MACULAR DEGENERATION HAS BEEN DETECTED. [MACULAR DEGENERATION] MY EYES ALWAYS BURN, MACULAR DEGENERATION HAS BEEN DETECTED. [BURNING IN EYES] CASE DESCRIPTION: ON 2024-10-24 A SPONTANEOUS CASE WAS REPORTED IN TURKEY BY A OTHER HEALTH PROFESSIONAL VIA (PHONE) CALL CENTER REPRESENTATIVE. THE REPORT CONCERNS A CONSUMER. THE CONSUMER RECEIVED COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1 (NAPC+POTM+TAED TABLET) (BATCH/LOT NUMBER: ASKED BUT UNKNOWN, EXPIRY DATE: UNKNOWN) FOR INDICATION PRODUCT USED FOR UNKNOWN INDICATION. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, AFTER AN UNKNOWN TIME OF STARTING COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1, THE CONSUMER EXPERIENCED A SERIOUS MEDICALLY SIGNIFICANT ADVERSE EVENT MY EYES ALWAYS BURN, MACULAR DEGENERATION HAS BEEN DETECTED (PREFERRED TERM: MACULAR DEGENERATION), THE CONSUMER EXPERIENCED ANOTHER NON SERIOUS ADVERSE EVENT MY EYES ALWAYS BURN, MACULAR DEGENERATION HAS BEEN DETECTED., (PREFERRED TERM: EYE IRRITATION). THE OUTCOME OF THE EVENTS MACULAR DEGENERATION AND EYE IRRITATION WAS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED. NO DRUG HISTORY WAS REPORTED. THE ACTION TAKEN WERE: FOR COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1 WAS UNKNOWN. DECHALLENGE WAS UNKNOWN AND RECHALLENGE WAS NOT APPLICABLE(NO-N/A). CAUSALITY OF THE EVENTS MACULAR DEGENERATION AND EYE IRRITATION WITH COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1 (NAPC+POTM+TAED TABLET) WAS NOT REPORTED/NOT ASSESSABLE. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. THE REPORTER PROVIDED THE FOLLOWING COMMENT: HELLO. I'M CALLING FROM PI PHARMACY PI. MY NAME IS PI. WE RECEIVED A COMPLAINT FROM A PATIENT ABOUT THIS COREGA TABLET. PATIENT REPORTED AS FOLLOWING: " SINCE I'VE BEEN USING IT, IT'S BEEN DOING SOMETHING AND I LEAVE IT IN THE BEDROOM. THE SMELL BOTHERS MY EYES UNTIL MORNING. WILL THIS CAUSE MACULAR DEGENERATION IN MY EYES. DOES IT HAVE THE POTENTIAL TO HARM ME BECAUSE I USE IT IN THE BEDROOM. MY EYES ALWAYS BURN, MACULAR DEGENERATION HAS BEEN DETECTED." GOOD DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166203 COREGA 3 MINUTE DENTURE CLEANSER 4 IN 1 DENTURE CLEANSER EFT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other