BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE

    MDR report key: 9224803 · Received October 22, 2019

    Report

    Report Number
    MW5090559
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 17, 2019
    Report Date
    October 21, 2019
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Product Code
    EBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A PRODUCT TOOTH FILING (RESIN) FROM EBAY THE SELLER NAME IS TBQUALITYPRODUCTS(953), NAME (B)(6), IT'S PACKING PRODUCT AT HOME. I GUESS THE PRODUCT DON'T COME IN BOX WITH ANY EXPIRATION DATE, JUST USE ZIP BAG AND PRINT EXPIRATION DATE WITH PRICE GUN. IT'S HARMFUL, I HAD ABSCESS AFTER USE IT UNTIL I GET MEDICAL TREATMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011886 PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE MATERIAL, TOOTH SHADE, RESIN EBF PRIME DENTAL MANUFACTURING, INC. 273935071593 EBAY

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR