BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 7764307 · Received August 8, 2018

    Report

    Report Number
    3005075853-2018-11960
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 1, 2017
    Report Date
    August 6, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ¿MAJOR BAND SLIP. COULDN¿T EAT OR DRINK FOR WEEKS. WAS ONLY ABLE TO SIP CLEAR LIQUIDS HERE AND THERE, ONLY ABLE TO KEEP DOWN MAYBE 4 OZ A DAY OF LIQUID. CHOKING AND ASPIRATING ON VOMIT IN MY SLEEP.¿ ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT; THE BAND WAS ORIGINALLY IMPLANTED IN (B)(6) IN 2005. PATIENT COULD NOT RECALL THE EXACT IMPLANT DATE. THE LAST BAND ADJUSTMENT WAS 5 YEARS AGO. THEY DECIDED TO HAVE THE BAND REMOVED. IT WAS REMOVED ON (B)(6) 2017. ONCE REMOVED, THERE WAS A TREMENDOUS AMOUNT OF SCAR TISSUE FROM WHERE THE BAND HAD SLIPPED. NO FLUID IN BAND AT THE TIME OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604555 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention