BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAGEL SURGICAL HEMOSTAT

    MDR report key: 2585542 · Received May 18, 2012

    Report

    Report Number
    2530131-2012-00009
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISCUSSION OF THIS EVENT WITH A THIRD PARTY PHYSICIAN, IT WAS NOTED THAT A HEMATOMA MAY DEVELOP IN A PROCEDURE SUCH AS THIS IF THE DEVICE IS NOT APPLIED CORRECTLY AND DISTRIBUTED THROUGHOUT THE SURGICAL SITE. IN THIS PROCEDURE, BLEEDING IS LIKELY NOT PROFUSE, BUT IS WIDESPREAD AND INADEQUATE APPLICATION OF THE DEVICE MAY LEAD TO HEMATOMA FORMATION. IT IS UNK WHETHER THIS OCCURRED IN THIS CASE. THERE HAS BEEN ONE OTHER REPORT FOR A HEMATOMA AFTER USE OF THIS DEVICE AND A CAUSAL LINK WAS NOT FOUND. HEMATOMA IS A NOTED RISK OF DEVICES IN THIS PRODUCT CODE AND IS LISTED IN THE DEVICE'S INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT. SHOULD FURTHER INFO BECOME AVAILABLE, A FALLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BREAST REDUCTION PROCEDURE DUE TO GYNECOMASTIA WAS COMPLETED USING SMALL INCISIONS. THE PROCEDURE WAS COMPLETED AND THE DEVICE WAS INSERTED FOR HEMOSTASIS. IT WAS REPORTED THAT A BILATERAL HEMATOMA DEVELOPED AFTER THE PROCEDURE. DRAINS WERE INSERTED AND THE PT IS RESOLVING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAGEL SURGICAL HEMOSTAT ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF ORTHOVITA, INC. A1110027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other