BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND

    MDR report key: 2571525 · Received May 11, 2012

    Report

    Report Number
    3005992282-2012-00068
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 6, 2012
    Report Date
    April 18, 2012
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. ADDITIONAL INFORMATION REPORTED BY THE SALES REP THE CUSTOMER WAS COMPLAINING OF NOT LOSING WEIGHT AND REQUESTED FOR THE BAND TO BE REMOVED. AS THE SURGEON WAS REMOVING THE BAND, THEY NOTICED THAT THE TUBING WAS COMPLETELY DISCONNECTED FROM THE PORT. THE STRAIN RELIEF WAS ALSO DISCONNECTED. THE STRAIN RELIEF WAS FOUND IN THE PATIENT AND WAS RETRIEVED. BOTH THE BAND AND PORT WERE REMOVED ON (B)(6) 2012 AND GIVEN TO THE PATIENT PER HER REQUEST. HE STATES THAT THE SURGEON INDICATED THE PATIENT HAD RESTRICTION, BUT HAVE ADJUSTMENTS AND THEN COME BACK AND HAVE THE FLUID REMOVE. THE SURGEON BELIEVES THAT THE PATIENT WAS NOT EATING CORRECTLY I.E. THE APPROPRIATE PORTIONS AND CHEWING FOOD AS SHE SHOULD. THE PATIENT PRESENTED AT ONE POINT WITH OBSTRUCTIVE SYMPTOMS AND THE SURGEON REMOVED LARGE PIECES OF PORK IN THE ESOPHAGUS. ACCORDING THE REP, THE SURGEON SAID PATIENT INDICATED THAT SHE HAD EATEN A SMALL PIECE, BUT THE FINDINGS WERE INCONSISTENT WITH WHAT THE PATIENT HAD REPORTED. # OF FILLS? 4 FILLS, BUT EMPTIED TWICE. WHEN DID THE PATIENT START COMPLAINING OF NOT LOSING WEIGHT? NEVER LOST MUCH WEIGHT, MAX (B)(6). COMPLAINED OF FOOD INTOLERANCE IN (B)(6) AND HAD THE BAND EMPTY SINCE THEN. IS THIS THE FIRST REPORT OF BAND TUBING DISCONNECTED? YES. WAS THE PATIENT DISCHARGED HOME AFTER THE BAND WAS REMOVED? THE PATIENT HOSPITALIZED OVERNIGHT. THE BAND WAS FORWARDED TO PATHOLOGY, DON'T KNOW HOW THEY DISPOSED OF IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT THAT POST IMPLANT A REALIZE BAND, THE PATIENT REQUESTED TO HAVE THE BAND REMOVED. THE PATIENT REPORTS THAT SHE WAS SEEN IN THE ER ON (B)(6) 2012 FOR FOOD THAT BECAME LODGED IN HER ESOPHAGUS. THE PATIENT WAS ADMITTED AND ON (B)(6) 2012 AN ENDOSCOPE WAS PERFORMED TO REMOVE PIECES OF PORK. THE ESOPHAGUS WAS STRETCHED AND THE FOOD WAS SUCTIONED OUT. ON (B)(6) 2012, THE PATIENT HAD A CT SCAN WITH DYE THAT CONFIRMED THE CATHETER CAME APART FROM THE INJECTION PORT SITE. THE PATIENT WAS RELEASED THE AFTERNOON OF (B)(6) 2012. SPOKE TO THE PATIENT ON (B)(6) 2012 AND SHE INDICATED THAT SHE HAS RETURNED TO WORK AND IS FEELING BETTER SINCE BAND REMOVAL. ASKED THE PATIENT IF THE SURGEON WAS ABLE TO LINK THE SYMPTOMS OF ORGAN INFLAMMATION TO THE BAND. SHE WAS NOT SURE. SHE STATES THAT WHEN THE BAND WAS REMOVED THE TUBING WAS NOT ATTACHED TO THE PORT AND THE "SLIDER" WAS NO LONGER ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZKMBP5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention