BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 2042124 · Received April 6, 2011

    Report

    Report Number
    3005992282-2011-00087
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    February 20, 2011
    Report Date
    March 14, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A BAND SLIPPAGE WAS REPORTED FOR A PATIENT ENROLLED IN THE SWEDISH ADJUSTABLE GASTRIC BAND REGISTRY. IN (B)(6) 2011, THE PATIENT PRESENT TO THE EMERGENCY ROOM WITH TOTAL FOOD BLOCKAGE, VOMITING AND DORSAL PAIN. A SCANNER EXAM SHOWED A TOTAL STENOSIS OF THE STOMACH AND A MEDIOGASTRIC SLIPPAGE. THE STOMACH WALL WAS ALSO ISCHEMIC. THE BAND WAS REMOVED WITHOUT ANY REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZHGBBG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention