BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLUTION,SALINE,IRRGATION,100ML,STRL

    MDR report key: 19173701 · Received April 24, 2024

    Report

    Report Number
    1417592-2024-00543
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 24, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE REPORTER, "SHE UNDERWENT A TUMMY-TUCK AND LIPOSUCTION PROCEDURE. SHE DEVELOPED COMPLICATIONS FROM THE SURGERY (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 NOTICED BLISTERING ABOVE HER WOUND. SHE EMERGENTLY WENT TO THE HOSPITAL AND WAS FOUND TO HAVE A BACTERIAL INFECTION OF HER ABDOMINAL WOULD-POCKET FILLED WITH PUS, BLOOD, AND FLUIDS. THE WOUND HAD TO BE DRAINED AND CLEANED. THE INFECTION WAS A RESULT OF USING NON-STERILE SALINE SOLUTION. THE REPORTER ALSO STATED THAT "THERE IS A DEEP HOLE WHERE THE INFECTION WAS IN HER ABDOMEN AND CONTINUES TO EXPERIENCE SEVERE PAIN, SUFFERING, AND DEPRESSION". THERE IS NO SAMPLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "SHE UNDERWENT A TUMMY-TUCK AND LIPOSUCTION PROCEDURE. SHE DEVELOPED COMPLICATIONS FROM THE SURGERY (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 NOTICED BLISTERING ABOVE HER WOUND. SHE EMERGENTLY WENT TO THE HOSPITAL AND WAS FOUND TO HAVE A BACTERIAL INFECTION OF HER ABDOMINAL WOULD-POCKET FILLED WITH PUS, BLOOD, AND FLUIDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382148 SOLUTION,SALINE,IRRGATION,100ML,STRL FRO MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other