BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1930710 · Received December 14, 2010

    Report

    Report Number
    2024601-2010-01021
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE MODEL NUMBER PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYS THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDING: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION¿"

    Description of Event or Problem · 1

    DOCTOR REPORTED AN EVENT OF "PAIN". THE EVENT LED TO A SERIOUS DETERIORATION IN THE HEALTH OF PT THAT REQUIRED IN-PATIENT HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 2018028

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R