BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITIME CORRECT FLOW

    MDR report key: 8694936 · Received June 13, 2019

    Report

    Report Number
    3011203516-2019-00001
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 13, 2019
    Manufacturer
    KULZER GMBH
    Product Code
    ELW
    PMA / PMN Number
    K091494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DENTIST NEEDS TO BE INFORMED BY THE PATIENT IF THERE ARE COMPLICATIONS LIKE PROBLEMS WITH STOMACH, INTESTINES, OR DIGESTION. IT IS EXPECTED THAT THE MATERIAL WILL LEAVE THE PATIENT ON A NATURAL WAY. THE PATIENT SHOULD LOOK AT BOWEL MOVEMENT. IF SHE RECOGNIZES THE GREEN CORRECT FLOW, EVERYTHING WILL BE FINE/OK. IF THERE OCCUR PROBLEMS, LIKE PAIN, PROBLEMS WITH DIGESTION OR SOMETHING ELSE, THE PATIENT SHOULD GO TO A CLINIC TO DO A STOMACH-INTESTINES REFLECTION. THIS, BECAUSE THE MATERIAL COULD BE A REASON FOR A BLOCKAGE IN THE STOMACH-INTESTINES TRACT. ON (B)(6) 2019, WE GOT THE FEEDBACK FROM THE DENTAL SURGERY THAT THE PIECE WAS FOUND IN THE STOOL. THE PATIENT DID NOT EXPERIENCE ANY TROUBLE AND IS DOING FINE.

    Description of Event or Problem · 1

    THIS OCCURRED IN (B)(6). DENTIST MADE AN IMPRESSION OF THE UPPER JAW, REGION 27, WITH FLEXITIME CORRECT FLOW. THE PATIENT SWALLOWED A BIT OF THE MATERIAL, IN THE SIZE OF A PEA/HAZELNUT. DENTIST HAS BEEN INFORMED THAT HE SHOULD KEEP CLOSE CONTACT FOR THE UPCOMING WEEKS (3-4) AND KEEP ASKING/UP TO DATE ABOUT THE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488785 FLEXITIME CORRECT FLOW IMPRESSION MATERIAL ELW KULZER GMBH K010108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other