BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COFLEX LF BANDAGE 1" STERILE

    MDR report key: 22850938 · Received August 20, 2025

    Report

    Report Number
    22850938
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ANDOVER HEALTHCARE INC. (A MILLIKEN HEALTHCARE LOC
    Product Code
    FQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OUTSIDE OF MANUFACTURERS BOX LABELING STATES "COFLEX LF BANDAGE 1"STERILE". INSIDE PACKAGING STATES "COFLEX LF BANDAGE 1" STERILE". WHAT IS ACTUALLY IN THE PACKAGING IS COFLEX LF BANDAGE 2" STERILE. PRODUCT IS MISLABELED. PRODUCT MISLABEL CAUGHT BEFORE GOING INTO OR SUPPLY CIRCULATION. THE 2" COFLEX IS TOO BIG TO BE USED FOR THE PURPOSE NEEDED IN HAND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155635 COFLEX LF BANDAGE 1" STERILE BANDAGE, ELASTIC FQM ANDOVER HEALTHCARE INC. (A MILLIKEN HEALTHCARE LOC DYNJ089001 25GBO086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown