BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    MDR report key: 4833662 · Received June 8, 2015

    Report

    Report Number
    3006722112-2015-00101
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    March 3, 2010
    Report Date
    January 26, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN EVENT OF POUCH DILATATION WITH AN UNKNOWN RELATION TO DEVICE; ACTION TAKEN TO TREAT THE EVENT IS UNKNOWN. HEALTHCARE PROFESSIONAL PREVIOUSLY REPORTED THE FOLLOWING NN REPORTABLE EVENTS: HEALTHCARE PROFESSIONAL REPORTED TWO EVENTS OF DYSPHAGIA. A LAP-BAND AP SYSTEM ADJUSTMENT TOOK PLACE TO TREAT EVENT. IT WAS RESOLVED WITHOUT SEQUELAE. DOCTOR REPORTED NON- RELATED HERNIA. DOCTOR REPORTED DYSPHAGIA, GASTROESOPHAGEAL REFLUX, NAUSEA, AND VOMITING TREATED WITH A LAP-BAND AP SYSTEM ADJUSTMENT. DOCTOR REPORTED NON-DEVICE RELATED OTHER, SPECIFYING "BREAST CANCER" TREATED WITH SURGERY ( LAP-BAND AP SYSTEM RELATED), SPECIFIED AS "MASTECTOMY" AND NON-DEVICE RELATED OTHER SPECIFYING, "CATARACT LEFT EYE" TREATED WITH SURGERY (NOT LAP-BAND AP SYSTEM RELATED), SPECIFIED AS "CATARACT SURGERY". HEALTHCARE PROFESSIONAL REPORTED ABDOMINAL PAIN WITH NO ACTION TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367869 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD) LTI ALLERGAN NA 1783130

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other