BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHOLL FREEZE (WITH SHIELD) KIT

    MDR report key: 6039502 · Received October 19, 2016

    Report

    Report Number
    3004142665-2016-00006
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ORASURE TECHNOLOGIES INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED PRODUCT WAS RECEIVED AT THE CANISTER MANUFACTURER, (B)(4), ON (B)(6) 2016 FOR FURTHER EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO DEVIATIONS WERE FOUND. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATIONS. RETAIN SAMPLES WERE PULLED AND TESTED AND MET PRODUCT SPECIFICATIONS. THE IMPLICATED PRODUCT WAS EXAMINED ON ITS TECHNICAL AND PRODUCT SPECIFICATIONS AND WERE WITHIN THOSE SPECIFICATIONS. A VISUAL EXAMINATION OF THE IMPLICATED PRODUCT WAS PERFORMED AND THE SHIELD WAS OBSERVED TO HAVE MELTING ON THE TOP. THE IMPLICATED PRODUCT WAS RECEIVED AT ORASURE TECHNOLOGIES, INC ON 07NOV2016. A VISUAL EXAMINATION OF THE IMPLICATED PRODUCT WAS PERFORMED AND THE MELTING OF THE UPPER PART OF THE SHIELD WAS CONFIRMED AS WELL AS A SMALL PATCH OF MELTED PLASTIC NEAR THE VALVE STEM. THE MELTING ON THE SHIELD WAS CONTAINED THE UPPER PORTION ON THE OUTSIDE ONLY CONSISTENT WITH AN EXTERNAL HEAT SOURCE. TESTING OF THE VALVE STEM DEMOSTRATED PROPER FUNCTIONING. FOLLOW UP WITH THE CONSUMER REVEALED A PREVIOUSLY LIT CANDLE THAT WAS EXTINGUISHED RIGHT BEFORE PRODUCT USE. THE PRODUCT CANNOT CATCH FIRE UNDER NORMAL ROOM TEMPERATURE CONDITIONS WITHOUT AN EXTERNAL SOURCE OF IGNITION DUE THE HIGH AUTO-IGNITION TEMPERATURE OF THE LIQUID CONTAINED IN THE CANISTER. BASED ON THE BATCH RECORD REVIEW, INVESTIGATIONS, AND CHECKS PERFORMED ON THE IMPLICATED PRODUCT, IT CAN ONLY BE CONCLUDED THAT THE PRODUCT IS MEETING ITS TECHNICAL AND FUNCTIONAL SPECIFICATIONS. SEE ATTACHED (B)(4) INVESTIGATION REPORT DATED (B)(6) 2016.

    Description of Event or Problem · 1

    A CONSUMER LOCATED IN (B)(6) REPORTED THAT THEY USED THE PRODUCT 2-3 TIMES WITHOUT INCIDENT. UPON USING THE PRODUCT AGAIN, THE CAN CAUGHT FIRE ON THE SPRAY HEAD AT WHICH POINT THEY DROPPED IT OFF THE TABLE CREATING THREE BURN MARKS ON THE CARPET. THE HAIR ON THE CONSUMER'S FOREARM ALSO CAUGHT FIRE.

    Description of Event or Problem · 1

    A CONSUMER LOCATED IN (B)(6) REPORTED THAT THEY USED THE PRODUCT 2-3 TIMES WITHOUT INCIDENT. UPON USING THE PRODUCT AGAIN, THE CAN CAUGHT FIRE ON THE SPRAY HEAD AT WHICH POINT THEY DROPPED IT OFF THE TABLE CREATING THREE BURN MARKS ON THE CARPET. THE HAIR ON THE CONSUMER'S FOREARM ALSO CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693798 SCHOLL FREEZE (WITH SHIELD) KIT SCHOLL FREEZE (WITH SHIELD) KIT GEH ORASURE TECHNOLOGIES INC. 1001-0184 5294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other