BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 209735 · Received February 9, 1999

    Report

    Report Number
    2028368-1999-00003
    Event Type
    Injury
    Date Received
    February 9, 1999
    Date of Event
    January 5, 1999
    Report Date
    January 20, 1999
    Manufacturer
    BIOENTERICS CORP.
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 01/19/1999, MEDI-PRO MEDICAL SUPPLIES, INC, BIOENTERICS CORP'S ISRAELI DISTRIBUTOR REPORTED TO BEC THAT DR REPORTED A SERIOUS ADVERSE EVENT THAT OCCURRED ON 01/05/1999. DR EXPLANTED A LAP-BAND (R) ADJUSTABLE GASTRIC BAND FROM A FEMALE PT ON 01/06/1999. THE SURGEON REPORTED THAT THE BAND MIGRATED INTO THE SMALL BOWEL. A PRODUCT FIELD NOTES FORM WAS PROVIDED TO THE SURGEON BY THE DISTRIBUTOR FOR THE PURPOSES OF OBTAINING EVENT RELATED DATA. HOWEVER, THE SURGEON DID NOT PROVIDE THE DEVICE'S CATOLOG NUMBER, LOT NUMBER, OR EVEN THE DATE OF IMPLANT. IN ADDITION, THERE WAS NO PT/MEDICAL INFORMATION DESCRIBING THE SET OF EVENTS THAT LEAD TO THE REPORTED EXPLANTATION PROCEDURES. IT WAS REPORTED THAT THE EXPLANTED DEVICE WILL NOT BE RETURNED AND THERE WAS NO INDICATION AS TO WHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Implant RESTRICTIVE DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| L| R