BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 13024683 · Received December 17, 2021

    Report

    Report Number
    1219930-2021-05251
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    April 26, 2021
    Report Date
    December 17, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: APPLICATION OF CONTRAST-ENHANCED ULTRASONOGRAPHY (CEUS) IN THE ASSESSMENT OF KIDNEY WOUND RECOVERY AFTER NEPHRON-SPARING SURGERY SOURCE: CANCER MANAGEMENT AND RESEARCH 2021:13 3925-3934. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, A STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC NEPHRON SPARING SURGERY OR ROBOT-ASSISTED NEPHRON-SPARING SURGERY BETWEEN APRIL 2019 AND JANUARY 2020. SUTURES ON NEEDLES WITH SURGICAL CLIPS WERE USED TO FROM OTHER COMPANY WERE USED TO REPAIR THE KIDNEY AFTER REMOVAL OF THE TUMOR. THERE WERE 90 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING. ONE PATIENT REQUIRED RADIOLOGIC INTERVENTION WITH ADMISSION FOR BLEEDING. BLOOD TRANSFUSIONS WERE ALSO REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930746 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H