BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAP¿ THERAPY SYSTEM

    MDR report key: 7561605 · Received June 1, 2018

    Report

    Report Number
    3009897021-2018-00053
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 1, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OKO
    PMA / PMN Number
    K132080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED WORSENED WOUND AND MACERATION REQUIRED MEDICAL OR SURGICAL INTERVENTION. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL CLINICAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE CUSTOMER: AFTER THE FIRST DRESSING CHANGE POST SNAP¿ THERAPY SYSTEM PLACEMENT ON THE PATIENT'S FINGER, THE WOUND ALLEGEDLY APPEARED WORSENED AND WAS MACERATED. THE SECURE RING ALLEGEDLY "SEEMED MELTED." NO ADDITIONAL INFORMATION IS AVAILABLE. A LOT NUMBER WAS NOT PROVIDED FOR THE SNAP¿ THERAPY SYSTEM THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404346 SNAP¿ THERAPY SYSTEM OKO OKO KINETIC CONCEPTS, INC. WNDSNP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other