BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M COBAN LF LATEX FREE SELF ADHERENT WRAP WITH HAND TEAR

    MDR report key: 3807432 · Received April 28, 2014

    Report

    Report Number
    2110898-2014-00025
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    January 14, 2013
    Report Date
    April 22, 2014
    Manufacturer
    3M HEALTHCARE
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2084S COBAN SELF ADHESIVE WRAP WAS APPLIED OVER EXTREMELY DRAPE DURING ROUTINE DRAPING FOR TOTAL KNEE REPLACEMENT. ALLEGED ON (B)(6) 2013, (B)(6) YEAR OLD FEMALE EXPERIENCED LEG LACERATION, REQUIRING SUTURES, POST KNEE REPLACEMENT WHEN THE WRAP WAS BEING REMOVED WITH BANDAGE SCISSORS. CUSTOMER REPORTED POLICY CHANGE FOR REMOVAL OF COBAN POST PROCEDURE. POLICY CHANGED FROM: REMOVE BY UNWRAPPING OR CUTTING WITH BANDAGE SCISSORS TO REMOVE BY UNWRAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254563 3M COBAN LF LATEX FREE SELF ADHERENT WRAP WITH HAND TEAR 880.5075 ELASTIC BANDAGE FQM 3M HEALTHCARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention