BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHOLL

    MDR report key: 12009572 · Received June 16, 2021

    Report

    Report Number
    3004142665-2021-00003
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL ISSUE WAS INTIATED IN THE ORASURE TECHNOLOGIES COMPLAINTS SYSTEM ON (B)(6) 2021 AWAITING FURTHER INFORMATION FROM THE REPORTER (B)(6). E-MAIL NOTIFICATION FROM (B)(6) ON 6/16/2021 STATED THERE WAS NO FURTHER INFORMATION TO BE PROVIDED ON THE INCIDENT AND THE PRODUCT WAS NOT AVAIALBLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED ON THE CONSUMER'S CONDITION. IT IS NOT KNOWN AS TO WHETHER THE CONSUMER SOUGHT ANY MEDICAL ATTENTION. BASED ON THE INFORMATION PROVIDED IT CAN NOT BE CONFIRMED IF THE PRODUCT USE WAS PER PRODUCT INSTRUCTIONS. PER PRODUCT INSTERUCTIONS, IT NOTES TO AVOID CONTACT WITH EYES AND MISUSE OF THE PRODUCT MAY RESULT IN BURNS OR PERMANENT SCARRING OF HEALTHY TISSUE OR BLINDNESS. WITHOUT THE CONSUMER'S USAGE DETAILS THIS CAN NOT BE CONFIRMED. NO FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY USED THE PRODUCT AS INSTRUCTED AND PLACED IT ON A TABLE AFTER USE. THE CONSUMER LATER HEARD A NOISE COMING FROM THE PRODUCT. THE CONSUMER PICKED UP THE PRODUCT AT THIS TIME AND CONTENTS FROM THE CANISTER LEAKED OUT COMING IN CONTACT WITH THE CONSUMER'S EYES AND SKIN. THE CONSUMER WAS ADVISED TO SEEK MEDICAL ATTENTION UPON REPORTING THIS INCIDENT. THE CONSUMER NOTED THAT AFTER WASHING THE EYE WITH COLD WATER IT STILL FELT IRRITATED. THE COMPLAINT WAS INITIATED INTERNALLY WITH ORASURE TECHNOLOGIES, INC. ON (B)(6) 2021. NO FURTHER INFORMATION IN REGARDS TO PRODUCT USAGE WAS PROVIDED AND THE PRODUCT WAS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910309 SCHOLL SCHOLL FREEZE GEH ORASURE TECHNOLOGIES, INC. 1001-0379 0065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other