BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE STERILE 0.9% NORMAL SALINE USP

    MDR report key: 18856979 · Received March 6, 2024

    Report

    Report Number
    MW5152437
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 8, 2023
    Report Date
    March 6, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - READYCARE HARTLAND
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO REPORT THAT SHE RECEIVED A LETTER (4 MARCH 2024) FROM MEDLINE NOTIFYING HER THAT THE STERILE SALINE THAT SHE IS USING HAS BEEN RECALLED DUE TO NON-STERILITY OF THE PRODUCT. REPORTER UNDERWENT A TUMMY-TUCK AND LIPOSUCTION PROCEDURE ON (B)(6) 2023. SHE DEVELOPED COMPLICATIONS FROM THE SURGERY IN (B)(6) (HEMATOMA, SEROMA, PAIN, ETC.) AND UNDERWENT A SECOND SURGERY FOR REPAIR (TISSUE REMOVAL). SHE WAS USING THE MEDLINE SALINE SOLUTION FOR WOUND-PACKING AND CARE AND ON (B)(6) 2024 NOTICED BLISTERING ABOVE HER WOUND. REPORTER EMERGENTLY WENT TO THE HOSPITAL AND WAS FOUND TO HAVE A BACTERIAL INFECTION OF HER ABDOMINAL WOUND-POCKET, FILLED WITH PUS, BLOOD, AND FLUIDS. THE WOUND HAD TO BE DRAINED AND CLEANED. THE INFECTION WAS A RESULT OF USING THE NON-STERILE SALINE SOLUTION. REPORTER NOW HAS A DEEP HOLE WHERE THE INFECTION WAS IN HER ABDOMEN, AND CONTINUES TO EXPERIENCE SEVERE PAIN, SUFFERING, AND DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341843 MEDLINE STERILE 0.9% NORMAL SALINE USP DRESSING, WOUND, DRUG FRO MEDLINE INDUSTRIES, LP - READYCARE HARTLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female