BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M TEGADERM CHG DRESSING

    MDR report key: 3875094 · Received June 10, 2014

    Report

    Report Number
    2110898-2014-00036
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 25, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT TYPE IS BEING MONITORED AND ANALYZED. TEGADERM CHG COMPLAINTS ARE SIGNIFICANTLY REDUCING BASED ON NUMBER OF UNITS SOLD. 3M'S UPDATES TO THE PACKAGE INSERT, ADD'L INSTRUCTION SHEETS, AND EDUCATIONAL PROGRAMS ARE BEING EFFECTIVE IN ENSURING OPTIMAL USE OF THE PRODUCT. ATTEMPTS WERE MADE TO DETERMINE THE CAUSE OF DEATH BUT INFO WAS NOT PROVIDED. CUSTOMER REPORTEDLY HAS RESUMED USE OF THE PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT WITH MOLDY SKIN SURFACE AROUND CENTRAL VENOUS CATHETER SITE. REPORTED ON (B)(6) 2014 EMERGENCY ROOM; (B)(6) 2014 EMERGENCY ROOM ICU, CVC INSERTION; (B)(6) 2014 TRANSFER TO GENERAL WARD, CHANGED DRESSING (DRESSING TYPE UNK); (B)(6) 2014 TRANSFER TO ICU, CHANGED DRESSING DUE TO OOZING (DRESSING TYPE: GAUZE PLUS TAPE); (B)(6) 2014 DRESSING CHANGE, TEGADERM CHG DRESSING APPLIED; (B)(6) 2014 PT EXPIRED, TEGADERM CHG DRESSING REMOVED AND CUSTOMER REPORTED PT HAD A GREEN MOLDY LIKE SKIN SURFACE AROUND CVC INSERTION SITE. REPORTED TEGADERM CHG DRESSING USED ONE TIME (FROM (B)(6) 2014). NO CULTURE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337365 3M TEGADERM CHG DRESSING UNCLASSIFIED - DRESSING, WOUND, DRUG FRO 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death