BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBL DRAPE CENTRAL LINE KIT

    MDR report key: 20181031 · Received September 10, 2024

    Report

    Report Number
    3004519921-2024-00038
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    May 4, 2024
    Report Date
    September 10, 2024
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    LRP
    UDI-DI
    00653160358193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 SKIN ISSUES WERE REPORTED WITH THE CHG GEL DRESSING DESCRIBED AS "WOUND WITH PRESENCE OF SLOUGH AT TIMES". PER THE FACILITY "NEW WOUND CARE ORDER PLACED, CLEAN WITH ANTISEPTIC, PAT DRY, APPLY SILVADENE CREAM, COVER WITH GAUZE AND CHANGE DRESSING DAILY". ADDITIONAL MEDICAL INTERVENTIONS WERE NOTED SUCH AS "REMOVAL OF CATHETER AND REPLACEMENT ON ANOTHER SITE". AT THIS TIME NO ADDITIONAL EVENT/PATIENT SPECIFIC DETAILS WERE PROVIDED RELATED TO THE REPORTED INCIDENT. THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2024 SKIN ISSUES WERE REPORTED WITH THE CHG GEL DRESSING DESCRIBED AS "WOUND WITH PRESENCE OF SLOUGH AT TIMES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223566 DBL DRAPE CENTRAL LINE KIT LRP CENTURION MEDICAL PRODUCTS, LP 2023012490 00653160358193

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other