BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 228960 · Received May 26, 1999

    Report

    Report Number
    228960
    Event Type
    Injury
    Date Received
    May 26, 1999
    Date of Event
    May 18, 1999
    Report Date
    May 24, 1999
    Manufacturer
    GUIDANT/ORIGIN MEDSYSTEM
    Product Code
    FHO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE HAVING A LAPAROSCOPIC REPAIR OF RT INGUINAL HERNIA, A STRUCTURAL BALLOON WAS INSERTED. BALLOON INFLATED WITH 4 HAND SQUEEZES OF HAND INSUFFLATOR. BALLOON POPPED, SURGEON INSERTED TELESCOPE AND CONFIRMED DEFLATED BALLOON. REMOVED STRUCTURAL BALLOON & INSERTED A PRE-PERITONEAL BALLOON, AND THEN TELESCOPE & FOUND URINARY BLADDER HAD BEEN COMPROMISED. BLADDER REPAIR DONE, TEMPORARY SUPRAPUBIC TUBE IN PLACE FOR 7-14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN PREPERITONEAL DISTENTION BALLOON FHO GUIDANT/ORIGIN MEDSYSTEM * 0102991

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R