BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIALIST EXTRA FAST

    MDR report key: 20378630 · Received October 4, 2024

    Report

    Report Number
    0001038963-2024-00001
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 4, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BSN MEDICAL S.A. DE C.V.
    Product Code
    ITG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF SAMPLES RETURNED FROM THE CUSTOMER PERFORMED ACCORDING TO SPECIFICATION. THIS EVALUATION WAS COMPLETED USING THE SAMPLES RETURNED FROM THE CUSTOMER WHICH WERE OF THE SAME LOT USED ON THE PATIENT DESCRIBED IN THIS COMPLAINT. THE EXACT PRODUCT WAS NOT AVAILABLE FOR EVALUATION AS IT HAD BEEN APPLIED AND REMOVED FROM THE PATIENT IN THE FIELD DURING THE PROCEDURE. IN ADDITION TO THE SAMPLES RETURNED BY THE CUSTOMER, THE MANUFACTURER ALSO TESTED RETAIN SAMPLES FROM THE ASSOCIATED LOT. ALL TESTING FOUND THE PRODUCT TO PERFORM ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REGARDING THE ALLEGED INCIDENT AND RETURN OF PRODUCT REQUESTED. NO SAMPLE RECEIVED AT THIS TIME. TESTING OF RETENTION SAMPLES SHOW PRODUCT PERFORMS ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 0

    PRODUCT SAMPLES WERE RETURNED FOR EVALUATION. TEST RESULTS ARE PENDING FINALIZATION. FOLLOW-UP REPORT WILL BE SUBMITTED ONCE TEST RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER INDICATED THEY MADE MULTIPLE ATTEMPTS TO SPLINT A PATIENT WHILE UNDER MODERATE SEDATION. THE CUSTOMER STATED THIS RESULTED IN THE PATIENT BEING UNDER SEDATION FOR A LONGER PERIOD OF TIME. THE CUSTOMER FURTHER DESCRIBED THAT THE PATIENT WAS "REQUIRED TO HAVE EXCESSIVE SEDATION, AND THE PHYSICIAN REQUIRED TO BE PRESENT AT BEDSIDE TO MONITOR AIRWAY." ADDITIONALLY, THE CUSTOMER NOTED THAT SINCE THEY COULD NOT GET THE 4 INCH PLASTER ROLLS TO SET, THE PHYSICIAN AND TECH CUT DOWN THE 6 INCH PLASTER ROLLS BECAUSE THE CONSCIOUS SEDATION WAS NOT A LONG-TERM OPTION FOR THE PROCEDURE. THEY NOTED THAT THIS WAS NOT OPTIMAL AND CAUSED FURTHER DELAY IN THE PROCEDURE BUT ALLOWED THE PHYSICIAN TO SPLINT THE PATIENT AS BEST AS POSSIBLE. UPON REQUESTING ADDITIONAL INFORMATION, THE CUSTOMER INDICATED THE PATIENT REQUESTED ADDITIONAL HOSPITAL STAY DUE TO THE OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602479 SPECIALIST EXTRA FAST PLASTER OF PARIS ITG BSN MEDICAL S.A. DE C.V. 72258-02 2431

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other