BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE COHESIVE BANDAGES

    MDR report key: 19660062 · Received July 1, 2024

    Report

    Report Number
    MW5156938
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 26, 2024
    Report Date
    June 28, 2024
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDICHOICE COHESIVE BANDAGES CBN1104 LOT # 24013H09A LEAVING BEHIND VISIBLE ADHESIVE RESIDUE ON GLOVES WHEN PERFORMING MANUAL MANIPULATION OF LEG DURING KNEE REPLACEMENT SURGERY. SURGEON AND TEAM DOUBLE GLOVE FOR DRAPING AND THEN REMOVE GLOVES AFTER. GLOVES WORN BY SURGEON ARE CARDINAL HEALTH PROTEXIS LATEX ORTHO SURGICAL GLOVES REF # 2D72LT80. ALSO OCCURRING TO OTHER MEMBERS OF TEAM WHEN ASSISTING WITH MANIPULATION OF LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552145 MEDICHOICE COHESIVE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX OWENS & MINOR DISTRIBUTION, INC. CBN1104 L 24013H09A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male