BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAGEL SURGICAL HEMOSTAT

    MDR report key: 2585540 · Received May 18, 2012

    Report

    Report Number
    2530131-2012-00007
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    March 30, 2012
    Report Date
    March 30, 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

    METHOD: AS NO DEVICE WAS RETURNED AND NO LOT NUMBER INFO WAS AVAILABLE, DEVICE AND DEVICE HISTORY REVIEWS COULD NOT BE COMPLETED. IN LIEU OF THESE, A LITERATURE SEARCH AND MAUDE DATABASE REVIEW WERE PERFORMED. SIMILAR INSTANCES (GRANULOMAS BASED ON FOREIGN BODY REACTION TO COLLAGEN HEMOSTATS) WERE NOTED IN LITERATURE. FURTHER APPROX 5% OF ALL REVIEWED MDRS MENTIONED GRANULOMA OR FOREIGN BODY REACTION. WHILE A REVIEW OF COMPLAINT HISTORY SHOWS NO REPORTED COMPLAINTS RELATING TO THE DEVICE AND GRANULOMA, IT SHOULD BE NOTED THAT THIS IS NOT AN UNEXPECTED ADVERSE EVENT BASED ON RESULTS FROM LITERATURE AND THE MAUDE DATABASE. CONCLUSION: IT IS UNK AT THIS TIME WHAT MAY HAVE CAUSED A FOREIGN BODY REACTION IN THIS CASE OR IF THERE IS A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT. SHOULD FURTHER INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL PROCEDURE DUE TO ENDOMETRIOSIS ON (B)(6), 2011. THE PROCEDURE PERFORMED WAS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND ENDOMETRIOSIS REMOVAL AND THE DEVICE WAS USED FOR HEMOSTASIS. ON APPROX (B)(6), 2012, A SECOND PROCEDURE WAS PERFORMED TO EXCISE WHAT WAS THOUGHT TO BE METASTATIC CANCER OF THE PELVIS. PATHOLOGY RETURNED GRANULOMAS SECONDARY TO A FOREIGN BODY REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O