BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 5147813 · Received October 9, 2015

    Report

    Report Number
    1718912-2015-00021
    Event Type
    Other
    Date Received
    October 9, 2015
    Date of Event
    September 29, 2015
    Report Date
    October 2, 2015
    Manufacturer
    ULTRADENT PRODUCTS, INC./ORA TECH LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT INFO RECEIVED 10/02/2015. CONSUMER REPORTED THAT SHE WAS SEEN IN THE EMERGENCY ROOM ON (B)(6) 2015 AND ADMITTED TO THE HOSPITAL. CONSUMER REPORTED THAT SHE WAS DISCHARGED ON (B)(6) 2015. CONSUMER REPORTED THAT SHE IS ALLERGIC TO PEG AND IT IS IN THE PRODUCT SO IT CAUSED HER TO HAVE AN ALLERGIC REACTION. HER ALLERGIC REACTION INCLUDED BURNING MOUTH, MOUTH DRY, FELLING ACHY, FEELING POORLY, MOUTH SORE, ROOF OF MOUTH SORE, THROAT SORE, SORE TONGUE, ITCHY ELBOWS, HER SKIN FELT FUNNY, FURTHER DESCRIBED AS IT FELT LIKE SHE APPLIED MENTHOL TO IT. CONSUMER REPORTED THAT SHE PASSED OUT ON (B)(6) 2015, WHICH HAS RESOLVED. ALL OTHER ADVERSE EVENTS HAVE IMPROVED BUT ARE NOT RESOLVED. CONSUMER REPORTED THAT SHE HAD AN UNRELATED FALL THAT SAME DAY SHE WAS ADMITTED TO THE HOSPITAL WHICH IS GIVING HER CHEST PAIN AND SHE HAD AN CHEST X-RAY FOR THIS. WHILE AT THE HOSPITAL THE CONSUMER HAD AN ECHOCARDIOGRAM, CAROTID ARTERY TEST, AORTA TEST, AND BLOOD WORK AND URINE TEST. ALL TEST WERE NORMAL. CONSUMER REPORTS SHE TAKES FLECAINIDE 5 MILLIGRAMS TWICE A DAY, LEXAPRO 5 MILLIGRAMS ONCE A DAY, PROTONIX 40 MILLIGRAMS ONCE A DAY, PRAVASTATIN 20 MILLIGRAMS ONCE A DAY, TORSEMIDE 6.25 MILLIGRAMS ONCE A DAY, COUMADIN 5 MILLIGRAMS ONCE A DAY ON MONDAY AND FRIDAY, COUMADIN 2.5 MILLIGRAMS ONCE A DAY ON TUESDAY, WEDNESDAY, THURSDAY, SATURDAY, SUNDAY. VICODIN 7.5-300 ONCE A DAY. CONSUMER DOES NOT HAVE A FOLLOW UP SCHEDULE NOR DID SHE LET THE DOCTOR KNOW SHE WAS USING THE PRODUCT. THIS CASE WAS MARKED AS A SERIOUS ADVERSE EVENT DUE TO THE HOSPITALIZATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP INFORMATION WAS RECEIVED ON OCTOBER 15, 2015 VIA AUTHORIZATION FORM TO CONTACT PHYSICIAN. THE CONSUMER'S AND HOSPITAL ADDRESS WAS PROVIDED. THE LOT NUMBER IS MENTIONED AS U5D171 WITH EXPIRATION DATE MARCH 20, 2019 AND ANOTHER LOT NUMBER MENTIONED AS 5020C1 WITH EXPIRATION DATE MARCH 2018.

    Additional Manufacturer Narrative · 1

    CO-SUSPECT PRODUCTS INCLUDED ORAL MOISTURISERS (BIOTENE MOUTHWASH (2013 FORMULATION)) MOUTH WASH (BATCH NUMBER 5020C1, EXPIRY DATE MARCH 20, 2018) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTIFICIAL CARDIAC PACEMAKER USER AND MULTIPLE ALLERGIES. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH) AND BIOTENE MOUTHWASH (2013 FORMULATION). ON (B)(6) 2015, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), BIOTENE MOUTHWASH (2013 FORMULATION), FLECAINIDE, PRAVASTATIN AND COUMADIN, THE PATIENT EXPERIENCED PASSED OUT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED CHEST PAIN AND FALL. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGIC REACTION (SERIOUS CRITERIA HOSPITALIZATION AND OTHER: SERIOUS ADVERSE EVENT), BURNING TONGUE, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT, BURNING IN THROAT, FEELING UNWELL, FAINTING AND SIXTH RIB FRACTURE. BIOTENE MOUTH SPRAY (SAVANNAH) WAS INTERRUPTED (DECHALLENGE WAS POSITIVE). RECHALLENGE WITH BIOTENE MOUTH SPRAY (SAVANNAH) WAS NEGATIVE. BIOTENE MOUTHWASH (2013 FORMULATION) WAS INTERRUPTED (DECHALLENGE WAS POSITIVE). RECHALLENGE WITH BIOTENE MOUTHWASH (2013 FORMULATION) WAS NEGATIVE. ON AN UNKNOWN DATE, THE OUTCOME OF THE ALLERGIC REACTION, BURNING TONGUE, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT, CHEST PAIN AND FALL WERE RECOVERING/RESOLVING AND THE OUTCOME OF THE PASSED OUT WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE BURNING IN THROAT, FEELING UNWELL, FAINTING AND SIXTH RIB FRACTURE WERE UNKNOWN. THE REPORTER CONSIDERED THE ALLERGIC REACTION, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION AND SORE THROAT TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PASSED OUT, BURNING TONGUE, BURNING IN THROAT, FEELING UNWELL, FAINTING AND SIXTH RIB FRACTURE TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH) AND BIOTENE MOUTHWASH (2013 FORMULATION). THE REPORTER CONSIDERED THE CHEST PAIN AND FALL TO BE UNRELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ALLERGIC REACTION, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT, CHEST PAIN AND FALL TO BE RELATED TO BIOTENE MOUTHWASH (2013 FORMULATION). THE FOLLOW UP INFORMATION WAS RECEIVED ON 15 OCTOBER 2015 VIA AUTHORIZATION FORM TO CONTACT PHYSICIAN. THE CONSUMER'S AND HOSPITAL ADDRESS WAS PROVIDED. THE LOT NUMBER IS MENTIONED AS U5D171 WITH EXPIRATION DATE MARCH 20, 2019 AND ANOTHER LOT NUMBER MENTIONED AS 5020C1 WITH EXPIRATION DATE MARCH 2018. THE FOLLOW UP INFORMATION WAS RECEIVED ON OCTOBER 19, 2015 VIA AUTHORIZATION FORM TO CONTACT PHYSICIAN. THE CONSUMER REPORTED VOGUE SYMPTOMS MOUTH, TONGUE, AND THROAT BURNING, SKIN FELT FUNNY, FELT SICK, FAINTED (BROKE 6TH RIB FOUND 2 WEEKS LATER). HE STOPPED BIOTENE THEN SYMPTOMS DISAPPEARED. HE TESTED IT AGAIN THEN SYMPTOMS RETURNED. HE ADMITTED THAT HE HAS ALLERGY TO POLYETHYLENE GLYCOL WHICH HE FOUND IT IN SPRAY HE CAN'T EXPLAIN ABOUT MOUTHWASH. THE BIOTENE MOUTH SPRAY WITH LOT NUMBER USD171 AND EXPIRATION DATE MARCH 20, 2017. THE BIOTENE MOUTH WASH WITH LOT NUMBER 5020C1 AND EXPIRATION DATE MARCH 20, 2018 WAS UPDATED IN THE CASE.

    Description of Event or Problem · 1

    ALLERGIC REACTION. PASSED OUT. FELLING ACHY [PAIN]. ARMS HURTING/ LEGS HURTING [PAIN IN ARM]. MOUTH BURNING/ MOUTH FELT ON FIRE [BURNING MOUTH]. ROOF OF MOUTH HURTS/ SORE MOUTH/ROOF OF MOUTH SORE [SORENESS ROOF OF MOUTH]. DRY TONGUE. FEELING POOR. ITCHY ELBOWS [PRURITUS]. MOUTH DRY. SKIN FELT FUNNY [DISTURBANCE OF SKIN SENSATION]. SORE THROAT. SORE TONGUE. CHEST PAIN. UNRELATED FALL. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ALLERGIC REACTION IN A (B)(6) YEAR OLD FEMALE PT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY ((B)(4))) UNK (BATCH NUMBER U5D171, EXPIRY DATE 03/31/2017) FOR PRODUCT USED FOR UNK INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTIFICIAL CARDIAC PACEMAKER USER AND MULTIPLE ALLERGIES. CONCOMITANT PRODUCTS INCLUDED FLECAINIDE, ESCITALOPRAM OXALATE (LEXAPRO), PROTONIX (NOS) (PROTONIX), PRAVASTATIN, TORASEMIDE, WARFARIN SODIUM (COUMADIN) AND HYDROCODONE BITARTRATE + PARACETAMOL (VICODIN). ON AN UNK DATE, THE PT STARTED BIOTENE MOUTH SPRAY ((B)(4)). ON (B)(6) 2015, AN UNK TIME AFTER STARTING BIOTENE MOUTH SPRAY ((B)(4)), FLECAINIDE, PRAVASTATIN AND COUMADIN, THE PT EXPERIENCED PASSED OUT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PT EXPERIENCED CHEST PAIN AND FALL. ON AN UNK DATE, THE PT EXPERIENCED ALLERGIC REACTION (SERIOUS CRITERIA HOSPITALIZATION), PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRAY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT AND SORE TONGUE. BIOTENE MOUTH SPRAY ((B)(4)) WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNK DATE, THE OUTCOME OF THE ALLERGIC REACTION, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT, SORE TONGUE, CHEST PAIN AND FALL WERE RECOVERING/RESOLVING AND THE OUTCOME OF THE PASSED OUT WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ALLERGIC REACTION, PAIN, PAIN IN ARM, BURNING MOUTH, SORENESS ROOF OF MOUTH, TONGUE DRY, FEELS POORLY, PRURITUS, DRY MOUTH, DISTURBANCE OF SKIN SENSATION, SORE THROAT AND SORE TONGUE TO BE RELATED TO BIOTENE MOUTH SPRAY ((B)(4)). IT WAS UNK IF THE REPORTER CONSIDERED THE PASSED OUT TO BE RELATED TO BIOTENE MOUTH SPRAY ((B)(4)). THE REPORTER CONSIDERED THE CHEST PAIN AND FALL TO BE UNRELATED TO BIOTENE MOUTH SPRAY ((B)(4)).

    Description of Event or Problem · 1

    UNRELATED FALL [FALL]. THROAT BURNING [BURNING IN THROAT]. FELT SICK [FEELING UNWELL]. FAINTED [FAINTING]. BROKE 6TH RIB [SIXTH RIB FRACTURE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672847 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS, INC./ORA TECH LLC U5D171

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O