BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAN SELF-ADHERING BANDAGE

    MDR report key: 6105956 · Received November 14, 2016

    Report

    Report Number
    MW5066064
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 14, 2016
    Manufacturer
    3M
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A TYPE II DIABETIC. ON (B)(6) 2016 I HAD A MINOR SURGICAL PROCEDURE ON ONE OF MY LOWER LEGS. THIS RESULTED IN A SUTURED INCISION OF ABOUT 2 INCHES. THE WOUND WAS COVERED WITH GAUZE AND THEN THE LEG WAS WRAPPED IN COBAN SELF-ADHESIVE BANDAGE EXTENDING APPROX. 3 INCHES ON BOTH SIDES OF THE WOUND. FIRST OF ALL, THE COBAN WAS VERY IRRITATING AND ABRASIVE TO MY SKIN AND CAUSED CONSIDERABLE SKIN IRRITATION. BECAUSE OF THE SKIN IRRITATION AND THE FACT THAT THIS TYPE OF BANDAGING BLOCKS THE VIEW OF THE WOUND I DID NOT REALIZE UNTIL 2 DAYS LATER THAT THE WOUND WAS INFECTED AND THE INFECTION HAD SPREAD BEYOND THE WOUND TO MY LOWER LEG GENERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750044 COBAN SELF-ADHERING BANDAGE COBAN SELF-ADHERING BANDAGE KGX 3M

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention COMBIGAN (GLAUCMOA EYE DROPS, ONCE DAILY)| FISH OIL SUPPLEMENT 1200 MG DAILY. | LATANOPROST (GLAUCMOA EYE DROPS, ONCE DAILY)| OTC MEDS: MULTI-VITAMIN DAILY| RETIN-A GEL, 0.1 PERCENT| RX MEDS: LIPITOR, 10 MG PER DAY| VITAMIN D-5000 I.U. DAILY