BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-CAST® SERENE

    MDR report key: 21913715 · Received April 25, 2025

    Report

    Report Number
    1038963-2025-00001
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 2, 2025
    Report Date
    June 4, 2025
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    LGH
    UDI-DI
    04042809876253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED AND RECEIVED BY THE CONTRACT MANUFACTURER FOR ADDITIONAL EVALUATION ON MAY 12, 2025. REPORT ISSUED MAY 22, 2025, INDICATES DEVICE PERFORMS ACCORDING TO SPECIFICATION. NOTE: AS REPORTED IN THE INITIAL REPORT, INITIAL INVESTIGATION OF RETURNED DEVICE WAS CONDUCTED BY THE SPECIFICATION DEVELOPER. DATE OF THIS EVALUATION WAS NOT PRESENT IN THE INITIAL REPORT; INITIAL EVALUATION WAS CONDUCTED (B)(6) 2025. AS NOTED IN THE INITIAL REPORT, THIS EVALUATION INDICATED THE PRODUCT PERFORMS ACCORDING TO SPECIFICATION. FOLLOWING THIS INVESTIGATION THE DEVICE WAS RETURNED TO THE CONTRACT MANUFACTURER FOR FURTHER EVALUATION. AS NOTED ABOVE, THIS EVALUATION ALSO FOUND THE PRODUCT TO PERFORM ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 0

    INITIAL INVESTIGATION OF RETURNED DEVICE INDICATES THE PRODUCT PERFORMS ACCORDING TO SPECIFICATION. PRODUCT WILL BE RETURNED TO CONTRACT MANUFACTURER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    DURING A DEMONSTRATION SESSION, ONE OF THE MEMBERS OF THE CASTING STAFF WAS USING THE CAST REMOVER TO REMOVE A CAST FROM THE ARM OF A COLLEAGUE. DURING THE REMOVAL, THE COLLEAGUE WITH THE CAST INDICATED THEY WERE EXPERIENCING PAIN IN THEIR ARM. THE USER STOPPED USE OF THE DEVICE AND BACKED THE DEVICE OUT. AFTER THE CAST HAD BEEN REMOVED, A BRUISE WITH A SMALL CUT WAS VISIBLE. A LATER TAKEN PICTURE OF THE AREA SHOWED AN APPROXIMATELY 2 CM LONG TEAR OF THE SKIN. THE INDIVIDUAL VISITED OCCUPATIONAL HEALTH FOR A TETANUS AND HEPATITIS B VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370688 DELTA-CAST® SERENE CAST REMOVER LGH BSN MEDICAL INC. 76289-08 00397 04042809876253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other