BEUDAMED
    FDA Adverse Event Summary report: N

    D-STAT FLOWABLE

    MDR report key: 1548260 · Received December 1, 2009

    Report

    Report Number
    2134812-2009-00035
    Date Received
    December 1, 2009
    Date of Event
    November 2, 2009
    Report Date
    December 1, 2009
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MHW
    PMA / PMN Number
    K012293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE REPORTED EVENT BY THE PATIENT, A REPRESENTATIVE OF THE MANUFACTURER CONTACTED DOCTOR'S HOSPITAL AT (B)(6) IN (B)(6). THE HOSPITAL CONFIRMED THAT THEY HAD A FEMALE PATIENT WHO RECEIVED A LIVER BIOPSY AT THE SAME TIME AS THE PATIENT WHO CONTACTED THE MANUFACTURER. THE HOSPITAL CONFIRMED THAT D-STAT FLOWABLE WAS USED FOR A LIVER BIOPSY, THE PATIENT EXPERIENCED PAIN AND WAS GIVEN PAIN MEDICATION. NO OTHER ADDITIONAL INFORMATION WAS OBTAINED. THE INSTRUCTIONS FOR USE FOR D-STAT FLOWABLE INCLUDE THE FOLLOWING STATEMENT: "THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH." IT IS MANUFACTURER'S CONCLUSION THAT THE USE OF D-STAT FLOWABLE FOR A LIVER BIOPSY IS AN OFF-LABEL USE OF THE PRODUCT.

    Description of Event or Problem · 1

    PATIENT CONTACTED CUSTOMER SERVICE REPORTING THAT SHE HAD A LIVER BIOPSY, EXPERIENCED PAIN, AND RECEIVED PAIN MEDICATION. THE PATIENT CONTACTED THE MANUFACTURER FOR PRODUCT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-STAT FLOWABLE HEMOSTAT MHW VASCULAR SOLUTIONS, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other