BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO 7

    MDR report key: 12597711 · Received October 8, 2021

    Report

    Report Number
    12597711
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 5, 2021
    Manufacturer
    SMITH NEPHEW MEDICAL LIMITED
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PUMP DID NOT WORK, WHEN PUT ON THE PATIENT-DID NOT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495467 PICO 7 NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH NEPHEW MEDICAL LIMITED 66022003

    Patients

    Seq Age Sex Outcome Treatment
    1