BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIO430 1P OPW MX W/W 40-45

    MDR report key: 5404544 · Received February 2, 2016

    Report

    Report Number
    9610694-2016-00002
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 2, 2016
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE, SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    END USER'S WEAR TIME STARTED COMING LOOSE IN 3-4 HOURS, THEN LASTED 1 DAY MAX. SKIN BEGAN TO BURN AFTER 3 DAYS OF THIS DUE TO LEAKAGE. WOULD LIFT AT BOTTOM AND ON SIDES. SKIN WAS INFECTED, HAD ABRASIONS; WENT TO ER, AND A NURSE ADVISED FOR HIM TO DO CRUSTING ROUTINE WITH POWDER AND BARRIER SPRAY AND REPEAT AS NEEDED. UNCLEAR WHETHER IT WAS TRULY INFECTED PER SE. THE SKIN HAS HEALED WELL AND IT IS FINE NOW. THIS WAS NOT HIS FIRST TIME USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62650 MIO430 1P OPW MX W/W 40-45 ADHESIVE / BASEPLATE EXB COLOPLAST A/S 1047901400 4597089

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention