BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1192843 · Received October 3, 2008

    Report

    Report Number
    3005992282-2008-00178
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    June 19, 2008
    Report Date
    September 8, 2008
    Manufacturer
    OBTECH MEDICAL SARL
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL. THE PT PRESENTED WITH ABDOMINAL PAIN IN 2008, AND IT WAS DISCOVERED THAT THE PT HAD AN ABSCESS. THE PT WAS ADMITTED TO HOSP, THE BAND WAS EXPLANTED AND THE PT WAS GIVEN ANTIBIOTICS. THE PT WAS DISCHARGED HOME WITHIN TWO DAYS. THE PT RETURNED SEVEN DAYS LATER WITH A FEVER AND VOMITING. IT WAS DISCOVERED THAT THE PT HAD A LIVER ABSCESS WHICH WAS BELIEVED TO HAVE ORIGINATED FROM THE SEROSITIS. THE ABSCESS WAS DRAINED, THE PT WAS PLACED ON IV ANTIBIOTICS, PUT ON AN NPO DIET, AND ANTIEMETICS FOR VOMITING. THE PT WAS HOSPITALIZED FOR SIX DAYS AND DISCHARGED HOME WITH NO OTHER COMPLICATIONS. AT THIS TIME, IT IS UNK IF THE PT WILL HAVE THE BAND REIMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE WITH MORBID OBESITY HAD UNDERWENT PLACEMENT OF A LAPAROSCOPIC GASTRIC BAND IN 2008 AND SHE WAS DISCHARGED HOME ON POD #1 WITHOUT COMPLAINTS. SHE RETURNED TWO WEEKS LATER WITH C/O ABDOMINAL PAIN AND FEVER. SEROSISTIS OF THE STOMACH WAS NOTED AND THE LAP BAND WAS THEREFORE REMOVED. THE PT WAS DISCHARGED AND RETURNED ONE WEEK LATER WITH FEVER. A CT SCAN PERFORMED AT THE TIME REVEALED A SUBPHRENIC ABSCESS THAT REQUIRED DRAINAGE IN INTERVENTIONAL RADIOLOGY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R