BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPACEMAKER BALLOON

    MDR report key: 13387299 · Received January 28, 2022

    Report

    Report Number
    2647580-2022-00313
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    March 12, 2021
    Report Date
    January 28, 2022
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: THE COMPARISON OF BALLOON AND CAMERA DISSECTION OF THE PREPERITONEAL SPACE IN TOTALLY EXTRAPERITONEAL REPAIR HERNIA REPAIR. OUR INITIAL EXPERIENCE SOURCE: SURGICAL INNOVATION 2021, VOL. 28(6) 695¿699 © THE AUTHOR(S) 2021 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/1553350621999297, JOURNALS.SAGEPUB.COM/HOME/SRI. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY COMPARED OUTCOMES OF BALLOON DISSECTION (BD) AND CAMERA DISSECTION (CD) FOR 40 PATIENTS UNDERGOING TOTALLY EXTRAPERITONEAL REPAIR (TEP). THE BALLOON DISSECTOR WAS USED WITH THE FOLLOWING COMPLICATIONS: HEMORRHAGE AND WOUND INFECTION. INTERVENTIONS NOT DISCUSSED. ARTICLE: THE COMPARISON OF BALLOON AND CAMERA DISSECTION OF THE PREPERITONEAL SPACE IN TOTALLY EXTRAPERITONEAL REPAIR HERNIA REPAIR. AUTHOR: SELIM BIROL YEAR: 2021, PUBLICATION: SAGE PUBLISHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641862 UNKNOWN SPACEMAKER BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO UNKNOWN SPACEMAKER BALLOON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other