BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAGEL SURGICAL HEMOSTAT

    MDR report key: 2234095 · Received August 29, 2011

    Report

    Report Number
    2530131-2011-00005
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - ANALYSIS OF LABELING PERFORMED - INFECTION AND CELLULITIS ARE LISTED IN THE VITAGEL IFU AS POSSIBLE ADVERSE EVENTS. DEVICE BATCH RECORD REVIEW WAS NOT POSSIBLE AS LOT NUMBER(S) ARE UNK. RESULTS - DEVICE USED IN APPROPRIATE ENVIRONMENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT WAS HOSPITALIZED WITH CELLULITIS FOR TWO DAYS AFTER UNDERGOING A TOTAL HIP ARTHROPLASTY IN WHICH THE DEVICE WAS USED. THE PT WAS PLACED ON KEFLEX AND THE INCISION WAS NOTED TO BE HEALING WELL WITH NO DRAINAGE NOTED. THERE WAS VERY LITTLE SWELLING ALONG THE ENTIRE LEG AND SOME ECCHYMOSIS NEAR THE BUTTOCKS. THE LATEST POST-OP VISIT NOTED SOME ERYTHEMA BY THE INCISION AND PAIN IN THE THIGH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O