BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1040611 · Received May 12, 2008

    Report

    Report Number
    3005992282-2008-00068
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 18, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4: INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WEEKS POST GASTRIC PROCEDURE, ORIGINALLY THOUGHT PATIENT WAS PRESENTING WITH A PE. PATIENT WAS SHORT OF BREATH AND "LOOKED LIKE A BYPASS PATIENT WITH A LEAK." PERFORMED A CT SCAN WITHOUT CONTRAST AT ANOTHER HOSPITAL BUT THE CT WAS CLEAR. PERFORMED AN UPPER GI, WHICH ALSO PRESENTED CLEAR. PATIENT'S WHITE COUNT WAS 14 AND THERE WAS NO PORT INFECTION. IN 2008, PATIENT WENT BACK INTO THE OR, AND THEY DISCOVERED PUSS AROUND THE TUBING AT THE PORT LOCATION AS WELL AS AROUND THE BAND. CULTURED BOTH AREAS. ALSO SCOPED THE PATIENT INTRAOPERATIVELY AND FOUND NOTHING. NO PERFORATION FOUND ANYWHERE. EXPLANTED THE BAND. THE PATIENT IS STILL IMPROVING, REMAINS ON A MONITORED UNIT, CONTINUES ON ANTIBIOTICS AND IS TOLERATING SOME ORAL INTAKE. WHITE COUNT IS 17. THE SOURCE OF INFECTION WAS GI TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R