BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COFLEX LF2 STERILE FOAM BANDAGE,

    MDR report key: 23545394 · Received November 12, 2025

    Report

    Report Number
    MW5178860
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 10, 2025
    Manufacturer
    PRODUCTOS MEDLINE S.A DE C.V
    Product Code
    FQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT NAME: COFLEX LF2 STERILE FOAM BANDAGE, TAN, 1" X 5 YD. (2.5 CM X 4.6 M) MANUFACTURER: MEDLINE INDUSTRIES, LP PRODUCT CODE: DYNJ089001; LOT (10)25GBO085; LOT (10)25GBO096. DESCRIPTION OF PROBLEM: THE OUTER LABEL INDICATES THE PRODUCT IS 1" COFLEX, BUT THE PRODUCT INSIDE IS 2". THIS ISSUE HAS BEEN OCCURRING SINCE (B)(6) 2025. WHEN ASKING MEDLINE ABOUT THE ISSUE, THEY CLAIM IT IS A "PLANNED SUBSTITUTION," AND DID NOT MENTION THE MANUFACTURING/LABELING ERROR. WE USE 1" COFLEX FOR HAND SURGERIES AND 2" COFLEX IS TOO LARGE FOR HANDS. THE LABELING ERROR WAS CAUGHT BEFORE THE PRODUCT WAS USED FOR PATIENT CARE AND NO ADVERSE EVENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922937 COFLEX LF2 STERILE FOAM BANDAGE, BANDAGE, ELASTIC FQM PRODUCTOS MEDLINE S.A DE C.V DYNJ089001 (10)25GBO085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown