BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET

    MDR report key: 23788735 · Received December 12, 2025

    Report

    Report Number
    3002808026-2025-00002
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    December 8, 2024
    Report Date
    December 12, 2025
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    GBX
    Removal / Correction Number
    RES 97994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SUPPLIED PACKS STATE "ALL YOU NEED TO ADD IS 1. GLOVES, 2. SKIN PREP 3. LOCAL ANAESTHETIC". THIS IS MISLEADING. THE SO CALLED "SKIN FIXATION DEVICE" IS NOT SUFFICIENT TO ANCHOR THE DRAIN IN PLACE AND SO A SUTURE IS ALSO REQUIRED. WITHIN THE VERY LARGE INSTRUCTION DOCUMENT IT IS STATED SOMEWHERE THAT THE DRAIN SHOULD BE SUTURED BUT IT IS NOT CLEAR ENOUGH. WE HAVE HAD AN INCIDENT OF A DRAIN FALLING OUT WHERE THE SKIN FIXATION DEVICE WAS USED ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703419 ROCKET SELDINGER KIT GBX ROCKET MEDICAL PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention