BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3807415 · Received April 28, 2014

    Report

    Report Number
    2110898-2014-00026
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    October 15, 2012
    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 2086S COBAN SELF ADHESIVE WRAP WAS APPLIED OVER EXTREMELY DRAPE DURING ROUTINE DRAPING FOR TOTAL HIP REPLACEMENT ON (B)(6) 2012. ALLEGED (B)(6) FEMALE EXPERIENCED LEG LACERATION, REQUIRING SUTURE AND STAPLE REPAIR, DURING REMOVAL OF WRAP FROM LOWER RIGHT EXTREMELY WITH BANDAGE SCISSORS POST HIP REPLACEMENT. FOLLOWING REPORTED EVENTS, CUSTOMER REPORTED POLICY CHANGE FOR REMOVAL OF COBAN WRAP POST PROCEDURE. POLICY CHANGED FROM REMOVAL BY UNWRAPPING OR CUTTING WITH BANDAGE SCISSORS TO REMOVAL BY UNWRAPPING ONLY. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254407 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 97 YR Required Intervention