BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2990308 · Received March 5, 2013

    Report

    Report Number
    3005992282-2013-00022
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    SUBJECT PRESENTED TO THE ER ON (B)(6)-2012, WITH SYMPTOMS OF AN ACUTE BAND OBSTRUCTION AND WAS DIAGNOSED WITH BAND SLIPPAGE VIA CT. THE SURGEON PERFORMED AN ATTEMPTED LAPAROSCOPIC BAND REVISION ON (B)(6)-2012 TO FIX THE SLIP, BUT A VERY SMALL GASTRIC ENTEROTOMY IN THE STOMACH OCCURRED INTRA-OP DURING DISSECTION. HE REPAIRED THE ENTEROSTOMY WITHOUT INCIDENT AND REMOVED THE REALIZE BAND COMPLETELY TO ALLOW THE STOMACH TO HEAL AND INFLAMMATION TO BE REDUCED. THE BAND WAS REPLACED ON (B)(6)-2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93844 REALIZE ADJ GASTRIC BAND STR IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention