BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1102015 · Received August 7, 2008

    Report

    Report Number
    2024601-2008-00409
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER TYPE II. MEDWATCH SENT TO FDA ON: 08/06/08. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN'S DIRECTIONS FOR USE LABELING STATES FOR ACCESS PORT PREPARATION: "INJECT STERILE SALINE TO IRRIGATE THE ACCESS PORT. AS IT FILLS, ALL AIR AND EXCESS FLUID WILL BE FORCE OUT OF THE TUBING AND PASS THE BLUNT FLUSHING NEEDLE." FOR BAND PREPARATION: "FILL A 20 CC SYRINGE WITH AT LEAST 15 CC OF SALINE AND CONNECT SYRINGE TO THE PRIMING NEEDLE. FLUSH THE BAND AND INFLATABLE SHELL AREA SEVERAL TIMES, EACH TIME DRAWING OUT AIR BUBBLES. A RESIDUAL AMOUNT OF SALINE WILL STAY IN THE LAP-BAND AP SYSTEM."

    Description of Event or Problem · 1

    REPORTED AS: "THE DOCTOR WAS TRYING TO PUT PORT IN DURING SURGERY, AND HE TRIED TO ASPIRATE FLUID OUT OF THE BAND HE WAS PUTTING IN, AND WAS UNABLE TO ASPIRATE ANY OF THE FLUID OUT. HE INJECTED 7ML AND COULD NOT GET ANY OUT. HE CUT THE SUTURES OUT OF THE FASCIA AND REMOVED THE PORT, AND PLACED ANOTHER PORT INTO THE PT. THIS WAS ALL DONE IN THE ORIGINAL SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1610312

    Patients

    Seq Age Sex Outcome Treatment
    1