BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 5078808 · Received September 15, 2015

    Report

    Report Number
    3006722112-2015-00350
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 17, 2015
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN TAPER. MEDWATCH SENT TO FDA ON: 09/15/2015. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER. TO DATE, APOLLO HAS NOT RECEIVED THE PRODUCT OR FURTHER INFORMATION REGARDING SERIAL NUMBER. WITHOUT SERIAL NUMBER OR DEVICE MODEL, TAPER TYPE CANNOT BE DETERMINED. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. LABELING ADDRESSES THE POSSIBILITY OF BUCKLE DISENGAGEMENT AS FOLLOWS: WARNING: "FAILURE TO SECURE THE BAND PROPERLY MAY RESULT IN ITS SUBSEQUENT DISPLACEMENT AND NECESSITATE A SECOND OPERATION." CAUTION: "FAILURE TO USE AN APPROPRIATE ATRAUMATIC INSTRUMENT TO LOCK THE BAND MAY RESULT IN DAMAGE TO THE BAND OR INJURY TO SURROUNDING TISSUES."

    Description of Event or Problem · 1

    REPORTED AS: SHORTLY AFTER PLACEMENT OF THE LAP-BAND SYSTEM, THE PATIENT LOST RESISTANCE. ACCORDING TO THE PHYSICIAN, EVIDENCE SHOWED THE ACTUAL BAND WAS NOT CLOSED. NO DIAGNOSTIC TESTS WERE NOTED IN THE CHART. THE LAP-BAND SYSTEM WAS EXPLANTED, AND THE PHYSICIAN NOTED A FRACTURE IN THE BUCKLING SYSTEM WITH NO OTHER ABNORMALITIES IN THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608414 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention