BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL POWDER ABSORBABLE HEMOSTAT

    MDR report key: 7369603 · Received March 26, 2018

    Report

    Report Number
    2210968-2018-71647
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    UDI-DI
    10705031237506
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: INDICATION OF USE OF THE PRODUCT: WHY WAS THE PRODUCT USED DURING THE INITIAL PROCEDURE? UNKNOWN. DATE AND EXACT NAME OF INITIAL PROCEDURE (PARTIAL OR TOTAL THYROIDECTOMY)? (B)(6) 2018, TOTAL THYROIDECTOMY. WHERE EXACTLY WAS THE PRODUCT USED: POWDER WAS USED ON TISSUE AFTER THYROID WAS REMOVED. WAS EXCESS PRODUCT IRRIGATED/REMOVED AFTER RECEIVING HEMOSTASIS, DURING THE PROCEDURE? IRRIGATION WAS NOT USED. ONSET OF SEROMA: UNKNOWN. WHAT ARE THE PATIENT¿S DEMOGRAPHICS? (AGE, DATE OF BIRTH, BMI, PAST MEDICAL HISTORY) NOT AVAILABLE. WHAT IS THE PATIENT¿S CURRENT STATUS? UNKNOWN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A THAT POST OP TO A TOTAL THYROIDECTOMY PROCEDURE ON (B)(6) 2018 AND ABSORBABLE HEMOSTAT WAS USED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A SEROMA. THE DOCTOR ASPIRATED 65 CC OF SEROUS FLUID AT THE BEDSIDE AT THE FIRST ADMISSION. AT THE SECOND ADMISSION, THE 170 CC OF SEROUS FLUID WAS ASPIRATED. ON A THIRD ADMISSION ON (B)(6) 2018, 55 CC OF SEROUS FLUID WAS ASPIRATED. THE PATIENT WAS DISCHARGED AFTER EACH ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213712 SURGICEL POWDER ABSORBABLE HEMOSTAT SURGICEL POWDER DEVICE LMG ETHICON INC. 10705031237506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention