BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-CAST SERENE

    MDR report key: 22572685 · Received July 22, 2025

    Report

    Report Number
    1038963-2025-00002
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    June 27, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    LGH
    UDI-DI
    04042809876253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT HAS BEEN REQUESTED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    AFTER RECEIPT, DEVICE WAS SENT TO THE CONTRACT MANUFACTURER FOR THE EVALUATION ON OCT 23,2025. CONTRACT MANUFACTURER COMPLETED DEVICE EVALUATION ON OCT 29, 2025. EVALUATION REPORT WAS ISSUED ON OCT 31, 2025. THE REPORT INDICATES DEVICE FUNCTIONED AS EXPECTED. NO IRREGULARITIES WERE OBSERVED.

    Description of Event or Problem · 0

    WHILE REMOVING A CAST USING THE DELTA CAST SERENE CAST REMOVER, THE PATIENT SUSTAINED AN INJURY TO THE INNER PART OF THE ARM, SLIGHTLY ABOVE THE ELBOW CREASE. THE CUT WAS MADE ON A CURVED AND SENSITIVE AREA, WHICH CONTRIBUTED TO THE INJURY. THE CAST REMOVER CAUSED A WOUND THAT REQUIRED SIX STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870666 DELTA-CAST SERENE CAST REMOVER LGH BSN MEDICAL INC. 76289-08 00421 04042809876253

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention