BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN

    MDR report key: 6826362 · Received August 29, 2017

    Report

    Report Number
    3008478369-2017-00005
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 22, 2017
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEPTEMBER 22, 2017: FERROSAN MEDICAL DEVICES A/S HAS COMPLETED THE EVALUATION OF THE RECEIVED ADVERSE EVENT. (B)(4).

    Description of Event or Problem · 1

    ON THE 29TH OF AUGUST, FERROSAN MEDICAL DEVICES A/S RECEIVED INFORMATION REGARDING THIS EVENT FROM OUR DISTRIBUTOR ETHICON: "IT WAS REPORTED BY THE SALES REP THAT AFTER A SPINAL PROCEDURE WHEN THE DEVICE WAS USED TO CLOSE THE INCISION THE PATIENT'S VITAL SIGNS CRASHED. THE PROCEDURE WAS ABORTED, RECEIVED CHEST COMPRESSIONS AND PUT ON A VENTILATOR. THE INCISION WAS CLOSED 3 DAYS LATER AFTER THE PATIENT HAD STABILIZED. (8/21) NO DEVICE WILL BE RETURNED." CLINICAL QUESTIONS ARE ASKED TO GATHER MORE INFORMATION REGARDING THE EVENT. (B)(4).

    Description of Event or Problem · 1

    ON THE 29TH OF AUGUST FERROSAN MEDICAL DEVICES A/S RECEIVED INFORMATION REGARDING THIS EVENT FROM OUR DISTRIBUTOR ETHICON: "IT WAS REPORTED BY THE SALES REP THAT AFTER A SPINAL PROCEDURE WHEN THE DEVICE WAS USED TO CLOSE THE INCISION THE PATIENT'S VITAL SIGNS CRASHED. THE PROCEDURE WAS ABORTED, RECEIVED CHEST COMPRESSIONS AND PUT ON A VENTILATOR. THE INCISION WAS CLOSED 3 DAYS LATER AFTER THE PATIENT HAD STABILIZED. (8/21) NO DEVICE WILL BE RETURNED." CLINICAL QUESTIONS ARE ASKED TO GATHER MORE INFORMATION REGARDING THE EVENT. ETHICON REFERENCE NO.: (B)(4). FERROSAN MEDICAL DEVICES A/S REFERENCE NO.: (B)(4). BEST REGARDS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606857 SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN SURGIFLO HEMOSTATIC MATRIX WITH THROMBIN PRODUCT CODE 2994 LMF FERROSAN MEDICAL DEVICES A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening