BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZED GASTRIC BAND

    MDR report key: 3872182 · Received June 9, 2014

    Report

    Report Number
    MW5036563
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    September 15, 2009
    Report Date
    June 6, 2014
    Manufacturer
    ALLERGAN INC
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 2009, LAPAROSCOPIC ADJUSTABLE GASTRIC BAND WAS SURGICALLY IMPLANTED USING THE REALIZED LAP-BAND FOR WEIGHT LOSS. LATER DEVELOPED WOUND INFECTION, OPEN OF THE SKIN SUTURE LINE; HAS BEEN EXPERIENCING PAIN AND TENDERNESS TO SITE, CONCESSIONAL VOMITING AND NAUSEA SINCE IMPLANT AND OCCASIONAL SWELLING/ENLARGEMENT AT PORT TIE. I HAVE HAD MULTIPLE BAND ADJUSTMENTS AND ESOPHAGOGASTRODUODENOSCOPY. WEIGHT LOSS TOTAL 35 LOBS. ON 2011, LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED DUE TO PRESENT OF GALLSTONES. I WAS INFORMED THAT THE SURGEON PROBED THE SITE OF BAND IMPLANT/ATTACHMENT. ON 2012 CHEST PAIN - CARDIAC CATH PERFORMED AND NEGATIVE. ON 2012, VISITED ANOTHER SURGEON FOR CONSULTATION AND TREATMENT. BAND ADJUSTMENTS AND EDGS DONE; HOWEVER, CONTINUE NAUSEA AND VOMITING, FILL RESTRICTIONS BUT NO ADDITIONAL WEIGHT LOSS. IN 2011 - 2013, DEVELOPED ELEVATED LIVER ENZYMES. REASON NOT FULLY DETERMINED, CONTINUE TO HAVE NAUSEA AND OCCASIONAL VOMITING. COULD IT POSSIBLE BE RELATED TO THE SILICONE BAND. AFTER THE GALLBLADDER SURGERY I DEVELOPED A LARGE, OR MULTIPLE INCISIONAL/ VENTRAL HERNIA. CURRENT PLAN IS FOR HERNIA REPAIR AND BAND REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334099 REALIZED GASTRIC BAND GASTRIC BAND LTI ALLERGAN INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability