BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1251759 · Received December 3, 2008

    Report

    Report Number
    3005992282-2008-00230
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 7, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 BY THE SURGEON THAT POST-OP OF A LAPAROSCOPIC GASTRIC BAND PROCEDURE, IN 2008, THE PT PRESENTED TO THE HOSP WITH ERYTHEMA AND TENDERNESS AT THE PORT SITE. THE PT WAS ADMITTED FOR PORT SITE INFECTION. THE INFECTION WAS TREATED WITH ANTIBIOTICS. THE PORT WAS REPOSITIONED ON THE FOLLOWING MONTH. THE PT IS IMPROVING WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND STR LTI IMPLANTED, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R