BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND SYSTEM

    MDR report key: 19886074 · Received August 1, 2024

    Report

    Report Number
    3013508647-2024-00054
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    March 1, 2024
    Report Date
    August 1, 2024
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION: NOTE: THIS COMPLAINT IS FROM BELGIUM. PHONE NUMBER FOR HEALTHLINK: (B)(6).

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORD FOR THE COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. AIR AND WATER LEAK TESTING PERFORMED ON PORT. NO EVIDENCE OF THE LEAK WAS DETECTED. THE PORT WAS FILLED WITH BLUE DYE SALINE (SALINE WITH BLUE DYE). NO EVIDENCE OF THE LEAK WAS DETECTED. THE PORT WAS FILLED WITH BLUE DYE SALINE AND PRESSURIZED FOR AN EXTENDED LEAK TEST. THE PORT WAS INSPECTED 1 DAY LATER. NO EVIDENCE OF THE LEAK WAS DETECTED AFTER 1 DAY. THE PORT WAS FILLED WITH BLUE DYE SALINE AND PRESSURIZED FOR AN EXTENDED LEAK TEST. THE PORT WAS INSPECTED 1 WEEK LATER. NO EVIDENCE OF THE LEAK WAS DETECTED AFTER 1 WEEK. THE LEAKAGE COULD NOT BE CONFIRMED AFTER THE LEAK TEST WAS PERFORMED. THE DEVICE HAS BEEN THROUGH THE LIFE TIME OF THE DEVICE (20 YEARS). UNABLE TO DETERMINE ROOT CAUSE OR CONDUCT TRENDING ANALYSIS. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. NO FURTHER ACTION TO BE TAKEN UNLESS THE COMPLAINANT PROVIDES ADDITIONAL INFORMATION. NO NEW RISKS IDENTIFIED, THE CURRENT RISK IS IDENTIFIED WITH A LOW RATE OF OCCURRENCE FOR THE REPORTED COMPLAINT CATEGORIES. NO CORRECTION OR CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    BROKEN GASTROPLASTY RING CATHETER. NO OTHER RELEVANT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240388 LAP-BAND SYSTEM ADJUSTABLE GASTRIC BAND LTI RESHAPE LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention