BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSHION GRIP

    MDR report key: 4121446 · Received September 22, 2014

    Report

    Report Number
    2210048-2014-00001
    Event Type
    Other
    Date Received
    September 22, 2014
    Report Date
    September 16, 2014
    Product Code
    KOP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER AND REFERS TO A MALE PT OF AN UNK AGE. ON AN UNK DATE, THE PT STARTED THERAPY WITH POLYVINYL ACETATE (CUSHION GRIP) FOR AN UNK INDICATION. NO OTHER CO-SUSPECTS WERE REPORTED. NO CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNK DATE, THE PT EXPERIENCED A "SERIES STROKES" (MEDICALLY SIGNIFICANT). THE PT ALSO REPORTED THAT THE PRODUCT HAD BECOME HARD. NO TREATMENT INFO WAS REPORTED. THE OUTCOMES OF THE PT'S "SERIES OF STROKES" AND THE PRODUCT BECOMING HARD WERE UNK. THE ACTION TAKEN WITH THE PRODUCT WAS UNK. THE REPORTER CONSIDERED HIS "SERIES OF STROKES" AND THE PRODUCT BECOMING HARD TO BE NOT RELATED TO POLYVINYL ACETATE (CUSHION GRIP). THE POLYVINYL ACETATE (CUSHION GRIP) WAS NOT AVAILABLE FOR INVESTIGATION. FOR POLYVINYL ACETATE (CUSHION GRIP), THE LOT NUMBER WAS ALBJ16, THE EXPIRATION DATE AND THE SERIAL NUMBER WERE NOT AVAILABLE. ADDITIONAL INFO IS NOT EXPECTED. UPDATE (B)(6) 2014: LOT NUMBER ALBJ16 WAS VERIFIED AS A VALID LOT NUMBER FOR POLYVINYL ACETATE (CUSHION GRIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587546 CUSHION GRIP DENTURE ADHESIVE KOP ALBJ16

    Patients

    Seq Age Sex Outcome Treatment
    1 Other