BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY RENTAL PUMP WITHOUT CASE

    MDR report key: 13181013 · Received January 6, 2022

    Report

    Report Number
    1419937-2022-00002
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 10, 2021
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367015578
    PMA / PMN Number
    K142626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE REFERRED THE PATIENT TO CALL THE DISTRIBUTOR IN ORDER TO ARRANGE A RETURN AND REPLACEMENT OF THE DEVICE SINCE IT WAS NOT IN USE BY THE PATIENT AT THE TIME OF THE CALL. IN FOLLOW UP WITH A MEDELA CLINICIAN ON (B)(6) 2022, THE CUSTOMER CONFIRMED HE HAD EXPERIENCED AN INFECTION, BUT HE WAS USING THE LIBERTY NEGATIVE PRESSURE WOUND VACUUM AGAIN AND IT WAS WORKING WITHOUT ISSUE. THE CLINICIAN ASKED IF SHE COULD SPEAK WITH HIS NURSE BUT THE PATIENT HUNG UP ON HER STATING HE DID NOT HAVE TIME. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE PATIENT CALLED IN TO MEDELA LLC AND ALLEGED THAT THE LIBERTY NEGATIVE PRESSURE WOUND VACUUM HAD BEEN TURNED OFF TWO DAYS AGO DUE TO AN AIR LEAK ALARM, WHICH THE PATIENTS' NURSE STATED LED TO A WOUND INFECTION. HE ADDITIONALLY ALLEGED THAT HE WAS BEING TREATED IN THE HOSPITAL WITH ANTIBIOTICS FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154941 LIBERTY RENTAL PUMP WITHOUT CASE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 101037810 07612367015578

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other