BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRAUMANN EMDOGAIN

    MDR report key: 4433295 · Received January 9, 2015

    Report

    Report Number
    1222315-2015-00001
    Event Type
    Other
    Date Received
    January 9, 2015
    Date of Event
    September 1, 2014
    Report Date
    January 8, 2015
    Manufacturer
    BIORA AB
    Product Code
    NQA
    PMA / PMN Number
    P930021
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE RISK MANAGEMENT REPORT "RISK MGMT REPORT - EMD PREFGEL OSTEOGAIN PDD-(B)(4) VERSION 1.0" CONFIRMS THAT INCAUTIOUS USE IN PATIENTS PRE-DISPOSED TO ALLERGIC REACTIONS IS ASSESSED AND REFLECTED IN THE IFU LABELLING 700019 STRAUMANN EMDOGAIN (US VERSION). THE REVIEW OF THE COMPLAINTS DATABASE CONFIRMS THAT NO FURTHER SIMILAR COMPLAINTS WITH THESE ARTICLE AND LOT NUMBERS HAVE BEEN REGISTERED. A PREVIOUS EVALUATION BY AN ALLERGIST STATES THAT THE ALLERGY POTENTIAL OF EMDOGAIN IS VERY LOW. THE MANUFACTURER REVIEWED MANUFACTURING BATCH RECORDS FOR BOTH 075.114 LOT GP625 (BOTH EMDOGAIN AND PREFGEL) AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    CLINICIAN REPORTS LACK OF WOUND HEALING AFTER A PERIODONTAL SURGERY TO TREAT AN INTRAOSSEOUS/FURCATION DEFECT WHICH WAS PERFORMED ON (B)(6) 2014. TREATMENT SITE: FD #23 - #24. SURGICAL TECHNIQUE WAS MINIMALLY INVASIVE. ON (B)(6) 2014 POST-OP SYMPTOMS INCLUDED SEVERE PAIN AND DISCOMFORT WITH SIGNS AS SEVERE SWELLING AND NECROSIS. THE CLINICIAN SUSPECTS AN ALLERGIC REACTION TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23964 STRAUMANN EMDOGAIN BIOLOGICAL MATERIAL, DENTAL NQA BIORA AB GP625

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other PREFGEL