BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO

    MDR report key: 8765980 · Received July 7, 2019

    Report

    Report Number
    8043484-2019-00470
    Event Type
    Malfunction
    Date Received
    July 7, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 21, 2019
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K112127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION INTO THE COMPLAINT HAS NOW CONCLUDED. NO SAMPLES WERE RECEIVED FOR THIS COMPLAINT THEREFORE VISUAL INSPECTION AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. NO LOT NUMBER WAS PROVIDED, THEREFORE A REVIEW OF BATCH MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ON THIS OCCASION WE ARE UNFORTUNATELY UNABLE TO REACH A DEFINITIVE ROOT CAUSE OF THE PROBLEM, HOWEVER SMITH AND NEPHEW ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS AND WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THREE DAYS OF TREATMENT THE PUMP WORKED FINE UNTIL THE PATIENT TOOK A SHOWER AND DID NOT DISCONNECT THE PUMP. ALL LIGHTS WERE SOLIDLY ILLUMINATING. NO MORE INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559719 PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1