BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONQ PUMP

    MDR report key: 10436839 · Received August 20, 2020

    Report

    Report Number
    MW5096184
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 19, 2020
    Manufacturer
    UNK
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED WITH SHORTNESS OF BREATH SINCE NERVE BLOCK (ON-Q) PLACED IN NECK FOR ROTATOR CUFF SURGERY. PATIENT HAD A RIGHT BRACHIAL PLEXUS BLOCK WITH AN ONQ PUMP PLACED AT OUTSIDE FACILITY AND PRESENTED TO INPATIENT HOSPITAL DIAGNOSED WITH RIGHT HEMIDIAPHRAGM PARALYSIS. PUMP WAS DISCONTINUED AND SYMPTOMS RESOLVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899583 ONQ PUMP PUMP, INFUSION, ELASTOMERIC MEB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R