BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY RENTAL PUMP WITHOUT CASE

    MDR report key: 12320312 · Received August 13, 2021

    Report

    Report Number
    1419937-2021-00061
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 20, 2021
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, THE PATIENT CONTACTED MEDELA LLC AND ALLEGED THAT THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP WAS NOT WORKING PROPERLY AND HE HAS BEEN BACK AND FORTH TO THE HOSPITAL WITH AN INFECTION. THE PATIENT ALLEGED HE IS ON ANTIBIOTIC AND IN THE HOSPITAL. THE PATIENT ALLEGED THAT HE REPORTED IT TO (B)(4), A MEDELA DISTRIBUTOR BETWEEN 2 AND 4 AM ON (B)(6) 2021, WHICH WAS THE FIRST CASE REPORTED ((B)(4)) TO MEDELA AND THE DEVICE WAS REPLACED BETWEEN 2:30 AND 3:30 PM THE SAME DAY. THE PATIENT ALLEGED THAT HE HAD TO GO BACK TO THE SURGICAL AREA DUE TO AN ABSCESS WHICH THEN CAUSED THE WOUND TO HEAL ON TOP AND NOT INSIDE. THE ABSCESS WAS PREVENTING THE SECOND WOUND VACUUM FROM CLEARING UP THE INFECTION. THE CUSTOMER ALLEGED THEY REMOVED THE ABSCESS AND MUSCLE TISSUE THAT HAD DIED DUE TO THE INFECTION. MEDELA WAS NOT NOTIFIED OF THIS UNTIL (B)(6) 2021. THE PUMP WAS NOT RETURNED BY (B)(4). MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION. ALSO SEE RELATED MEDWATCH 1419937-2021-00060 AND 1419937-2021-00062.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE PATIENT CONTACTED MEDELA LLC AND AS A RESULT, MEDELA LLC FOUND OUT THAT THE PATIENT'S PUMP HAD BEEN REPLACED BY (B)(4), A MEDELA DISTRIBUTOR. MEDELA CONTACTED (B)(4) ON (B)(6) 2021 AND LEARNED OF THE FOLLOWING INFORMATION. MEDELA FOUND OUT THAT SN (B)(4) (THE ORIGINAL PUMP) WAS REPLACED WITH SN (B)(4) ON (B)(6) 2021 AND SN (B)(4) WAS PICKED UP BY (B)(4)-NO FURTHER INFORMATION GIVEN TO MEDELA LLC. PATENT CALLED MEDELA ON (B)(6) 2021 STATING THAT HE WANTED OUR INSURANCE INFORMATION FOR A CLAIM DUE TO THE INFECTION HE ASSOCIATED WITH THE (B)(6) PUMP. PATIENT STATED THAT (B)(4) INSTRUCTED HIM TO CALL US TO FILE A CLAIM. MEDELA CUSTOMER SERVICE SPOKE WITH (B)(4) AT (B)(4) BRANCH WHO PROVIDED THE HISTORY OF THE ABOVE SERIAL NUMBERS. MEDELA CUSTOMER SERVICE REVIEWED THEIR PHONE RECORDS AND THE ONLY INTERACTION THE PATIENT HAD WITH MEDELA WAS ON (B)(6) 2021 AND (B)(6) 2021. PATIENT DID NOT CONTACT HIS NURSE OR PHYSICIAN AND WAS AWARE OF THE 2 HOUR WINDOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214519 LIBERTY RENTAL PUMP WITHOUT CASE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 101037810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other