BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL NASAL SPLINT - SEPTAL BUTTON

    MDR report key: 11701647 · Received April 21, 2021

    Report

    Report Number
    1045254-2021-00190
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 21, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LFB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SURVEY WAS CONDUCTED WHERE THE HCP RESPONDED WITH THE FOLLOWING INFORMATION: SPLINT WAS TORN OR PARTIALLY TORN WITH NON-VISIBLE PRODUCT NUMBER. THE FIRST DEVICE OPENED WAS NOT USED ON PATIENT BECAUSE IT WAS DEFORMED. AFTER THE SURGERY, THE PATIENT EXPERIENCED SEROMA, SKIN BLISTERING OR ULCERATION, SKIN IRRITATION, FISTULA, PROLONGED IMPAIRED SENSE OF SMELL AND SCARRING. THERE WAS ALSO BIOFILM FORMATION AND SEPTAL ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596899 INTERNAL NASAL SPLINT - SEPTAL BUTTON LFB MEDTRONIC XOMED INC. 9124105

    Patients

    Seq Age Sex Outcome Treatment
    1