BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1181135 · Received September 30, 2008

    Report

    Report Number
    3005992282-2008-00176
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    June 20, 2008
    Report Date
    September 3, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GASTRIC BAND SURGERY TOOK PLACE. AN INFECTION AT THE PORT SITE WAS DETECTED ON NINE DAYS LATER. PT WAS PRESCRIBED ZITHROMAX (1 WEEK) THEN TWO WEEKS OF CLINDAMYCIN, THEN A FEW WEEKS LATER, ANOTHER TWO WEEKS OF CLINDAMYCIN AND THEN WAS PUT ON TWO MORE WEEKS WHEN THE PORT WAS REMOVED. THE PORT WAS REMOVED IN 2008. AFTER THE PORT REMOVAL SURGERY, THE PT RECEIVED IN HOME NURSE CARE FOR THE WOUND. PT IS GOING TO HAVE SURGERY TWO MONTHS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention