BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMADYNE PENTA L

    MDR report key: 203769 · Received December 22, 1998

    Report

    Report Number
    9611385-1998-00010
    Event Type
    Injury
    Date Received
    December 22, 1998
    Date of Event
    November 26, 1998
    Report Date
    November 27, 1998
    Manufacturer
    ESPE DENTAL AG
    Product Code
    EBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON 11/27/1998 A DENTIST CALLED AND REPORTED AN ADVERSE EVENT INVOLVING PERMADYNE PENTA L, AN IMPRESSION MATERIAL MANUFACTURED BY ESPE. THE DENTIST DID AN IMPRESSION IN A PATIENT WHO WAS RECENTLY TREATED BY IMPLANTOLOGY. THE MATERIAL DID NOT CURE AND SOAKED INTO THE STITCHES OF THE JUST REMOVED SUTURE. AS A RESULT OF AN ACCOMPANYING INFECTION TWO IMPLANTS WERE REJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMADYNE PENTA L POLYETHER BASED IMPRESSION MATERIAL EBH ESPE DENTAL AG NA FW0044233

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention