BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROGEN 5 ALGINATE

    MDR report key: 3981457 · Received July 25, 2014

    Report

    Report Number
    9614794-2014-00001
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    April 13, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ZHERMACK S.P.A.
    Product Code
    ELW
    PMA / PMN Number
    K974704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AN ADULT FEMALE PATIENT WHOSE CURRENT CONDITIONS INCLUDING SMOKING, METASTASES TO BONES AND BONE PAIN EXPERIENCED A REACTION AFTER HAVING AN IMPRESSION TAKEN WITH HYDROGUM 5. THE PATIENT HAS RECEIVED AFINTOR (EVEROLIMUS) FOR THE TREATMENT OF METASTATIC BREAST CANCER SINCE (B)(6) 2012 AT A DOSE OF 10 MG PER DAY, ORALLY. THE PATIENT HAS RECEIVED EXEMESTAN (EXEMESTANE) FOR TREATMENT OF BREAST CANCER SINCE (B)(6) 2012 AT A DOSE OF 1 MG DAILY, ORALLY. SHE HAD AN IMPRESSION TAKEN WITH HYDROGUM 5 ON (B)(6) 2014. ON (B)(6) 2014, WHILE ON THERAPY WITH AFINITOR/EXEMESTAN THE PATIENT DEVELOPED APHTHOUS STOMATITIS (MOUTH ULCERS) AND GLOSSITIS. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED PAIN AND EDEMA. AFINITOR THERAPY WAS ONGOING. THE EVENTS, "SEVERE" APHTHOUS STOMATITIS AND GLOSSITIS AFTER THE DENTAL IMPRESSION WERE ASSESSED AS "SERIOUS MEDICALLY SIGNIFICANT AND DISABILITY" (DEBILITATING). IT WAS REPORTED THAT THE PATIENT HAD RECOVERED AS OF (B)(6) 2014. THE EVENTS WERE SUSPECTED TO BE RELATED TO A DRUG INTERACTION BETWEEN AFINITOR/EXEMESTAN AND THE IMPRESSION MATERIAL, HYDROGUM 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436647 HYDROGEN 5 ALGINATE IMPRESSION MATERIAL ELW ZHERMACK S.P.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXEMESTAN (EXEMESTANE)| IBUHEXAL (IBUPROFEN)| AFINITOR (EVEROLIMUS)| XGEVA (DENOSUMAB)| SPIRO COMP (FUROSEMIDE)| PALEXIA (TAPENTADOL HYDROCHLORIDE)