BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2800974 · Received October 18, 2012

    Report

    Report Number
    2024601-2012-01118
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    May 23, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2012. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. VISIBILITY/PALPABILITY AND PAIN ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF VISIBILITY/PALPABILITY AS FOLLOWS: PRECAUTIONS: 6. CARE MUST BE TAKEN TO PLACE THE ACCESS PORT IN A STABLE POSITION AWAY FROM AREAS THAT MAY BE AFFECTED BY SIGNIFICANT WEIGHT LOSS, PHYSICAL ACTIVITY, OR SUBSEQUENT SURGERY. FAILURE TO DO SO MAY RESULT IN THE INABILITY TO PERFORM PERCUTANEOUS BAND ADJUSTMENTS.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED, "EXPLANTED PORT/SURGERY ELSEWHERE/HAD A PROTRUDING PAINFUL PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention