BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY RENTAL PUMP WITHOUT CASE

    MDR report key: 12487811 · Received September 17, 2021

    Report

    Report Number
    1419937-2021-00080
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    August 30, 2021
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367015578
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDELA CLINICIAN GAVE THE NURSE INSTRUCTIONS ON WOUND PREPARATION AND DRESSING SET UP TO AVOID POSSIBLE ALLERGIC REACTION TO ACRYLIC IN FILM. THE CLINICIAN GAVE THE NURSE INSTRUCTIONS TO CALL BACK WITH AN UPDATE IF THE ALLERGIC REACTION DID NOT RESOLVE. ON 9/13/2021, A MEDELA CLINICIAN FOLLOWED UP WITH THE DIRECTOR OF WOUND CARE AT THE HOSPITAL TO GET ADDITIONAL INFORMATION ON THE PATIENT. THE DIRECTOR STATED THAT THE PATIENT RECEIVED CLARITIN AND SOLUMEDROL AND IT HELPED TREAT THE REACTION. THE PATIENT WAS NOT PLACED BACK ON THE DEVICE. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION.

    Description of Event or Problem · 1

    ON 08/30/2021, THE NURSE AT (B)(6) HOSPITAL CONTACTED MEDELA LLC AND ALLEGED THAT THE PATIENT HAD A POSSIBLE ALLERGIC REACTION FROM THE FILM AT FOUR WOUND SITES WHILE USING THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389375 LIBERTY RENTAL PUMP WITHOUT CASE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 101037810/16283M 07612367015578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other