BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY RENTAL PUMP WITHOUT CASE

    MDR report key: 12489526 · Received September 17, 2021

    Report

    Report Number
    1419937-2021-00081
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    August 24, 2021
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367015578
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE EMAILED THE DISTRIBUTOR AND REQUESTED THEY SEND THE PATIENT A REPLACEMENT DEVICE. ON (B)(6) 2021, THE PATIENT WAS CONTACTED BY A MEDELA CLINICIAN AND HE INDICATED THE DEVICE HAD NOT BEEN PULLING THE DRAINAGE AS IT HAD BEEN BEFORE SO HE WENT TO THE EMERGENCY ROOM. HE ADDITIONALLY INDICATED THAT WHEN A DOCTOR IN THE EMERGENCY ROOM LOOKED AT THE WOUND HE GAVE THE HIM THE PRESCRIPTION FOR ANTIBIOTICS AND THE DEVICE HAD BEEN REMOVED FROM HIM FOR 48 HOURS. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT THEY HAD GOTTEN AN INFECTION WHILE USING THE MEDELA LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP AND HAD GONE TO THE DOCTOR WHO PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390269 LIBERTY RENTAL PUMP WITHOUT CASE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 101037810 07612367015578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other