BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAN 2 LAYER COMPRESSION SYSTEM

    MDR report key: 5033259 · Received August 26, 2015

    Report

    Report Number
    2110898-2015-00036
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    May 8, 2015
    Report Date
    August 17, 2015
    Manufacturer
    3M HEALTH CARE
    Product Code
    FQM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FROM INSTRUCTIONS FOR USE: PRODUCT DESCRIPTION.... THE COMPRESSION SYSTEM IS INTENDED FOR SINGLE USE ONLY AND MAY BE WORN UP TO SEVEN DAYS. WARNINGS.... WRAPPING TOO TIGHTLY MAY IMPAIR CIRCULATION. MONITOR THE AREA OF APPLICATION FREQUENTLY FOR SIGNS OF DISCOLORATION, PAIN, NUMBNESS, TINGLING OR OTHER CHANGES IN SENSATION AND SWELLING. IF THESE SYMPTOMS OCCUR, REMOVE 3M COBAN COMPRESSION SYSTEM PROMPTLY AND CONTACT YOUR HEALTH CARE PROVIDER. PRECAUTIONS... COBAN 2 LITE SHOULD BE USED UNDER THE SUPERVISION OF A LICENSED HEALTH CARE PROFESSIONAL. PATIENTS WITH KNOWN ARTERIAL INSUFFICIENCY, DECOMPENSATED HEART INSUFFICIENCY OR DIABETES WITH ADVANCED SMALL VESSEL DISEASE MAY NOT TOLERATE COMPRESSION. IN DIABETIC PATIENTS, COBAN 2 LITE SHOULD BE USED WITH CAUTION DUE TO THE POSSIBILITY OF MICROVASCULAR DISEASE. CONSIDERATIONS..... PATIENTS SHOULD BE ADVISED TO PROMPTLY CONTACT THEIR HEALTH CARE PROVIDER IF THEY EXPERIENCE PAIN, NUMBNESS, TINGLING, DISCOLORATION OR SWELLING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B)(6) MALE WITH A DIAGNOSIS OF VENOUS ULCERS, DIABETIC ULCERS AND ARTERIAL ULCERS HAD 2794 COBAN 2 LAYER LITE COMPRESSION SYSTEM APPLIED TO BILATERAL LEGS FOR TREATMENT OF VENOUS ULCERS. CUSTOMER REPORTED FIRST APPLICATION OF 2794 COBAN 2 LAYER LITE OCCURRED ON (B)(6). ADDITIONAL APPLICATION DATES WERE REPORTED AS (B)(6) - NO PROBLEMS, (B)(6) NO PROBLEMS AND (B)(6) NO PROBLEMS. ON (B)(6) CUSTOMER REPORTED THE PATIENT HAD GAINED SIGNIFICANT WEIGHT AND ANASARCA (EXTREME GENERALIZED EDEMA), COMPRESSION WRAPS WERE DISCONTINUED, PATIENT WAS SENT TO THE ER, WAS HOSPITALIZED FOR FLUID OVERLOAD AND RECEIVED DIALYSIS. CUSTOMER REPORTED COMPRESSION THERAPY WAS APPLIED WHILE PATIENT WAS IN THE HOSPITAL ON (B)(6) AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO NURSING HOME ON (B)(6). CUSTOMER REPORTED THE PATIENT WENT TO THE NURSING HOME WITH THE COMPRESSION WRAPS ON AND WAS SEEN IN THE WOUND CARE CLINIC ON (B)(6) 2015. CUSTOMER REPORTED PATIENT EXPERIENCED A NEW WOUND ON HIS LEFT LEG /SHIN WHICH STARTED IN THE HOSPITAL AS REDNESS AND ON (B)(6) 2015, LEFT LEG/SHIN -ESCHAR TO WOUND MEASURED 14 X1 X 0.2. CUSTOMER REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) FOR WOUND DEBRIDEMENT (UNSPECIFIED PROCEDURE DATE). CUSTOMER ALSO REPORTED COMPRESSION THERAPY WAS APPLIED AGAIN ON (B)(6) 2015 WHILE THE PATIENT WAS IN THE HOSPITAL . CUSTOMER REPORTED THE WOUND WAS THEN TREATED AS FOLLOWS: (B)(6) 2015 SANTYL, (B)(6) MEDIHONEY, (B)(6) 2015 HYDROGEL, (B)(6) 2015 SANTYL, (B)(6) 2015 HYDROGEL, (B)(6) 2015 SILVADENE AND (B)(6) 2015 SILVADENE. CUSTOMER REPORTED THE WOUND IS HEALING AND ON (B)(6) AND MEASURED 4.8 X 1.2 X 0.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564297 COBAN 2 LAYER COMPRESSION SYSTEM ELASTIC BANDAGE, PRODUCT CODE FQM FQM 3M HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R