BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1924863 · Received December 14, 2010

    Report

    Report Number
    3005992282-2010-00446
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 29, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THER BAND WAS REMOVED DUE TO BAND EROSION IN (B)(6) 2010. XRAYS WERE DONE WHICH SHOWED AN EROSION. THE PATIENT REPORTS DOING FINE WITH NO OTHER COMPLICATIONS.

    Description of Event or Problem · 1

    SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED ADDITIONAL INFORMATION. PER THE PATIENT, SHE HAD THREE FILLS PRIOR TO BAND REMOVAL. SHE REPORTS DOING FINE FOR THE FIRST YEAR OR SO AND THEN BEGAN TO SEE A DECREASE IN WEIGHT LOSS AND BEGAN TO HAVE PAIN IN LOWER STOMACH AND PELVIC AREA. SHE SOUGHT MEDICAL ADVICE FROM SEVERAL DOCTORS WITH NO DIAGNOSIS. PATIENT STATES THAT IN (B)(6) 2010, SHE ATE A FEW PEANUTS AND IMMEDIATELY HAD SEVERE PAIN. PATIENT WENT TO THE ER AND THE ER STAFF RELATED THE PAIN TO DIVERTICULITIS. THE PAIN CONTINUED AND THE PATIENT STATES GOING TO HER PRIMARY CARE PHYSICIAN (PCP) TWO DAYS LATER. THE PCP CONTACTED THE IMPLANTING SURGEON WHO ADVISED TO HAVE THE PATIENT TRANSPORTED VIA AMBULANCE TO HOSPITAL IN (B)(6) WHERE SHE WAS ADMITTED. THE BAND WAS REMOVED THE BAND ALONG WITH ONE-THIRD OF THE STOMACH DUE TO TISSUE NECROSIS. DRAINAGE TUBES WERE PLACED AND THE PATIENT REMAINED IN THE HOSPITAL FOR SEVEN DAYS. THE PATIENT STATES THAT SHE CONTINUES TO HAVE SOME STOMACH PAIN, BUT GETTING BETTER WITH MEDICATION TAKEN PRIOR TO EATING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention