BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TEGADERM CHG DRESSING

    MDR report key: 6846864 · Received September 6, 2017

    Report

    Report Number
    2110898-2017-00110
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 6, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED BY REPORTER. NO LOT NUMBER WAS AVAILABLE. WITHOUT A LOT NUMBER, EXPIRATION DATE AND MANUFACTURER DATE CANNOT BE DETERMINED. NO SAMPLE OR LOT NUMBER HAS BEEN RECEIVED TO DATE SO A BATCH RECORD REVIEW MAY NOT BE PERFORMED. THIS REPORT INVOLVES THE SAME PATIENT IN REPORT 2110898-2017-00109. A NURSE REPORTED THE (B)(6) MALE PATIENT EXPERIENCED ADVERSE INCIDENTS WHEN TEGADERM CHG DRESSINGS WERE APPLIED TO HIS INTERNAL JUGULAR CATHETER SITE (1658 TEGADERM CHG DRESSING 2110898-2017-00109) AND ARTERIAL CATHETER (1660 TEGADERM CHG DRESSING 2110898-2017-00110) SITES. A SKIN REACTION MAY BE RELATED TO A NUMBER OF FACTORS INCLUDING SITE PREPARATION, APPLICATION, AND SITE MAINTENANCE. THE PACKAGE INSERT PROVIDES THE FOLLOWING INFORMATION: PRECAUTIONS: THE SKIN SHOULD BE DRY AND FREE OF DETERGENT RESIDUE. ALLOW ALL PREPS AND PROTECTANTS TO DRY COMPLETELY BEFORE APPLYING THE DRESSING TO PREVENT SKIN IRRITATION AND TO ENSURE GOOD ADHESION. SITE PREPARATION..... PREPARE THE SITE ACCORDING TO INSTITUTION PROTOCOL. CLIPPING OF HAIR AT SITE MAY IMPROVE DRESSING ADHESION. SHAVING IS NOT RECOMMENDED. THE SKIN SHOULD BE CLEAN, DRY AND FREE OF DETERGENT RESIDUE. ALLOW ALL PREPS AND PROTECTANTS TO DRY COMPLETELY BEFORE APPLYING THE DRESSING TO PREVENT SKIN IRRITATION AND TO ENSURE GOOD ADHESION....... SITECARE: THE SITE SHOULD BE OBSERVED DAILY FOR SIGNS OF INFECTION OR OTHER COMPLICATIONS.... INSPECT THE DRESSING DAILY AND CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL. DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS AND MAY BE NEEDED MORE FREQUENTLY WITH HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED. THE TEGADERM(TM) CHG DRESSING SHOULD BE CHANGED AS NECESSARY: IF THE DRESSING BECOMES LOOSE, SOILED OR COMPROMISED, IF THE SITE IS OBSCURED OR NO LONGER VISIBLE, IF THERE IS VISIBLE DRAINAGE OUTSIDE THE GEL PAD, IF THE DRESSING APPEARS TO BE SATURATED OR OVERLY SWOLLEN. TO TEST IF THE DRESSING IS FULLY SATURATED, LIGHTLY PRESS DOWN ON A CORNER OF THE GEL PAD WITH YOUR FINGER. IF THE GEL PAD REMAINS DISPLACED ONCE YOUR FINGER IS REMOVED, THE DRESSING SHOULD BE CHANGED. NOTE: TEGADERM¿ CHG DRESSING IS NOT DESIGNED TO ABSORB LARGE QUANTITIES OF BLOOD OR FLUID.

    Description of Event or Problem · 1

    A NURSE REPORTED A (B)(6) MALE PATIENT EXPERIENCED A 0.5CM X 0.5CM (DEPTH 0.3 CM) WOUND WHEN A 1660 TEGADERM CHG DRESSING WAS APPLIED TO AN ARTERIAL CATHETER SITE IN HIS LEFT WRIST FOR SIX DAYS. THE PATIENT WAS SEEN BY THE WOUND CLINIC AND REQUIRED ANTIMICROBIAL SILVER CLOTH TYPE DRESSING CHANGES DAILY FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627289 3M TEGADERM CHG DRESSING TEGADERM CHG DRESSING FRO 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention