BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTHWASH (UNKNOWN)

    MDR report key: 17469531 · Received August 7, 2023

    Report

    Report Number
    3012293198-2023-00027
    Event Type
    Injury
    Date Received
    August 7, 2023
    Report Date
    July 5, 2023
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 0

    PHYSICAL DECONDITIONING [PHYSICAL DECONDITIONING] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A NON-HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF PHYSICAL DECONDITIONING IN A PATIENT IN 80S WHO RECEIVED GLYCERIN (BIOTENE MOUTHWASH (UNKNOWN)) MOUTH WASH FOR AN UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED BEDRIDDEN. IN (B)(6) 2023, THE PATIENT STARTED BIOTENE MOUTHWASH (UNKNOWN). IN (B)(6) 2023, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTHWASH (UNKNOWN), THE PATIENT EXPERIENCED PHYSICAL DECONDITIONING. BIOTENE MOUTHWASH (UNKNOWN) WAS DISCONTINUED IN 2023 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE PHYSICAL DECONDITIONING WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PHYSICAL DECONDITIONING TO BE RELATED TO BIOTENE MOUTHWASH (UNKNOWN). THIS REPORT IS MADE BY GSK/HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. [CLINICAL COURSE]: PATIENT: IN HIS LATE 80S. IN (B)(6) 2023, THE PATIENT STARTED BIOTENE MOUTHWASH (UNKNOWN). THE BEDRIDDEN PATIENT PURCHASED BIOTENE MOUTHWASH (UNKNOWN) AND USED IT FOR SEVERAL MONTHS. DURATION OF USE: FOR SEVERAL MONTHS FROM (B)(6) 2023. IN (B)(6) 2023, ALTHOUGH IT WAS UNKNOWN IF THE USE OF BIOTENE MOUTHWASH (UNKNOWN) WAS RESPONSIBLE, THE PATIENT EXPERIENCED PHYSICAL DECONDITIONING FROM (B)(6) 2023 TO (B)(6) 2023. THE PHYSICAL DECONDITIONING TEMPORARILY PROGRESSED TO A LIFE-OR-DEATH CONDITION (SERIOUSNESS: NON-SERIOUS). FOLLOW-UP INFORMATION RECEIVED FROM THE REPORTING NON-HEALTH PROFESSIONAL VIA A MEDICAL REPRESENTATIVE ON 05 JULY 2023. PATIENT: AN 88-YEAR-OLD MALE. FOLLOW-UP INFORMATION RECEIVED ON 11 JULY 2023. [CLINICAL COURSE]: INTERMEDIARY WAS A MEDICAL REPRESENTATIVE. CONCOMITANT DRUG: UNKNOWN. COMPLICATION/MEDICAL HISTORY: UNKNOWN. IN (B)(6) 2023, ALTHOUGH IT WAS UNKNOWN IF THE USE OF BIOTENE MOUTHWASH (UNKNOWN) WAS RESPONSIBLE, THE PATIENT EXPERIENCED PHYSICAL DECONDITIONING FROM (B)(6) 2023 TO (B)(6) 2023. THE PHYSICAL DECONDITIONING TEMPORARILY PROGRESSED TO A LIFE-OR-DEATH CONDITION (SERIOUSNESS: DISABILITY). TREATMENT FOR ADVERSE EVENT: NONE AROUND (B)(6) 2023, THE PATIENT EXPERIENCED PHYSICAL DECONDITIONING. THE OUTCOME OF THE PHYSICAL DECONDITIONING TEMPORARILY PROGRESSED TO A LIFE-OR-DEATH CONDITION WAS RESOLVED. THE PATIENT HAD FELT BETTER IN (B)(6) THAN (B)(6). IT APPEARED THAT THE PATIENT WAS CONTINUOUSLY USING BIOTENE ON A REGULAR BASIS. [REPORTER'S COMMENT]: THE PATIENT HAD BEEN BEDRIDDEN SINCE BEFORE USING THE PRODUCT. HE REQUIRED NURSING AND HAD BEEN IN A SPECIAL ELDERLY NURSING HOME. AS HE WAS USING THE RETRIEVED PRODUCT AT THE TIME OF PHYSICAL DECONDITIONING, THE REPORTER ASKED IF THERE WOULD BE ANY CAUSALITY JUST IN CASE. CAUSALITY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222375 BIOTENE MOUTHWASH (UNKNOWN) ORAL RINSES LFD KIK CUSTOM PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Disability