BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1161676 · Received September 16, 2008

    Report

    Report Number
    3005992282-2008-00155
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THE PT UNDERWENT A GASTRIC BAND PROCEDURE IN '08. THE PT WAS GIVEN ANCEF 2 GM IV PRE-OPERATIVELY. THE SKIN WAS PREPPED WITH BETADINE GEL. MARCAINE 1/4% WITH EPINEPHRINE WAS INJECTED FOR POST-OP INCISIONAL PAIN. THE INCISION WAS CLOSED WITH SUBCUTANEOUS CLOSURE OF 4-0 MONOCRYL. MASTISOL AND STERI-STRIPS WERE PLACED OVER THE INCISION. THE 4X4 DRESSING AND TEGADERM DRESSING WERE USED. PT WAS DISCHARGED THE SAME DAY. THE PT WAS SEEN ON AN UNK DATE IN THE EMERGENCY ROOM (ER) AT METHODIST SPECIALITY AND TRANSPLANT HOSP FOR WOUND INFECTION OVER THE PORT SITE. THE AREA WAS DEBRIDED IN THE ER BY THE ER PHYSICIAN. PT WAS PRESCRIBED ANTIBIOTICS AND DISCHARGED HOME. THERE WERE NO OTHER PT COMPLICATIONS REPORTED. THE PT HAD NO KNOWN ALLERGIES.

    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