BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLI-GRIP S/JAPAN L

    MDR report key: 179825 · Received July 30, 1998

    Report

    Report Number
    9681138-1998-00001
    Event Type
    Other
    Date Received
    July 30, 1998
    Date of Event
    May 1, 1998
    Report Date
    July 27, 1998
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A 62 YEAR OLD MALE EXPERIENCED A RASH ON HIS WHOLE BODY AND DIFFICULTY BREATHING 20 TO 30 MINUTES AFTER HIS FIRST APPLICATION OF POLIGRIP S DENTURE ADHESIVE. THE REPORTER STATED THAT THE CONSUMER APPLIED THE PRODUCT TO HIS DENTURES, INSERTED THEM IN HIS MOUTH, THEN IMMEDIATELY REMOVED HIS DENTURES AND RINSED HIS MOUTH BECAUSE HE DID NOT LIKE THE ODOR OF THE PRODUCT. APPROXIMATELY 20 TO 30 MINUTES LATER A RASH APPEARED AND DYSPNEA OCCURRED. THE CONSUMER SOUGHT MEDICAL TREATMENT AT A NEARBY HOSPITAL WHERE HE WAS ADMINISTERED SOLU-CORTEF I.V. (HYDROCORTISONE SODIUM SUCCINATE), KYOMINOTIN I.V. (GLYCYRHIZIN, AMINOBUTYRIC ACID, CYSTEINE), TATHION I.V. (GLUATHIONE), POLARAMINE I.V. (CHLORPHENIRAMINE MALEATE), ACELART I.V. (LIVER EXTRACT FLAVIN ADENIN DINUCLEOTIDE), VITA C.I.V. (ASCORBIC ACID), LACTATED RINGER'S SOLUTION AND AN INFRARED LIGHT IRRADIATION TREATMENT. TESTING REVEALED AN ELEVATED IGE LEVEL (938/ML). THE CONSUMER WAS RELEASED WITH THE MEDICATIONS DAREN (EMEDEASTINE DIFUMARATE) AND JUMIHAIDOKUTO (CHINESE HERB MEDICINE), AND RCLAR (DEPRODONE PROPIONATE) AND PALDES (CLOBETASONE BUTYRATE) FOR EXTERNAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLI-GRIP S/JAPAN L DENTURE ADHESIVE KOO BLOCK DRUG COMPANY, INC. * D307J

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization NONE REPORTED.