BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVERLET

    MDR report key: 10520682 · Received September 10, 2020

    Report

    Report Number
    MW5096536
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    September 5, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    NAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A (B)(6) YEAR OLD MALE WHO IS IN PRETTY GOOD SHAPE. RECENTLY, I HAD MINOR HOUSEHOLD INCIDENTS, SCRAPING OR OTHER WAYS IN CAUSING MINOR WOUNDS. MY TREATMENT WITH NEOSPORIN SEEMED TO WORK BUT THE WOUND WAS ITCHING CRAZILY AND SOMEHOW HAS NOT HEALED. THE BANDAGE WE HAPPENED TO HAVE IS COVERLET, MADE FOR (B)(6), WHICH IS EASY TO APPLY. BECAUSE SECRETIONS CONTINUED, MY WIFE THOUGHT I MIGHT BE ALLERGIC AND I AGREED, ESPECIALLY WHEN I SAW TODAY SOME RED DOTS ON UPPER SIDE OF MY LEFT HAND AND UPPER SIDE OF MY RIGHT ARM. THEY DO NOT LOOK LIKE A COINCIDENCE. WHETHER RELEVANT OR NOT, THE ENVELOPE IN WHICH THE BANDAGE COMES SAYS IT IS LATEX-FREE. I DO NOT RECALL WHETHER I AM ALLERGIC TO LATEX; USUALLY, I JUST BUY WHATEVER BAND-AID OFFERS. WHETHER A LATEX SUBSTITUTE IS A PROBLEM, YOU WOULD KNOW BETTER THAN I. NOT REALLY. HAVING STOPPED, I AM CURIOUS WHETHER I INDEED HAVE HAD AN ALLERGIC REACTION AND WHAT I DO WITH MY REMAINING SUPPLY. REACTION TO BANDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983464 COVERLET DRESSING, WOUND, OCCLUSIVE NAD BSN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other