BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 2871600 · Received December 11, 2012

    Report

    Report Number
    2024601-2012-01281
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. PRIOR TO THE REPORT, A PIECE OF TUBING WAS REMOVED BUT ALLERGAN HAS NOT BEEN ABLE TO CONFIRM IF IT WAS DISCARDED. THE TUBING WAS REATTACHED AND REMAINS IMPLANTED. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE 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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REATTACHED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE TREATING PHYSICIAN AND FACILITY HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING THE EVENT AND THE STATUS OF THE REMOVED TUBING. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING." DEVICE LABELING ADDRESSES THE REPORTED EVENT TO PAIN AS FOLLOWS: "11. PATIENTS MUST BE CAREFULLY COUNSELED ON THE NEED TO REPORT ALL VOMITING, ABDOMINAL PAIN OR OTHER GASTROINTESTINAL OR NUTRITIONAL ISSUES AS THESES SYMPTOMS MAY INDICATE A CONDITION NOT RELATED TO THE LAP-BAND SYSTEM."

    Description of Event or Problem · 1

    PATIENT DESCRIBES ADVERSE EVENT AS "LAPAROSCOPY PERFORMED TO INVESTIGATE ABDOMINAL PAIN. TUBING HAS BECOME DETACHED FROM BAND; PORT STILL IN-SITU." FURTHER INFORMATION - SPOKE TO PATIENT, WHO MENTIONED THAT THE PHYSICIAN AT THE TREATING HOSPITAL CHOPPED THE TUBING OF THE BAND AS IT WAS HANGING IN HER UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) LTI ALLERGAN NA 1744737

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention