BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1974464 · Received January 31, 2011

    Report

    Report Number
    3005992282-2011-00029
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    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) DEVICE RETAINED BY ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SIX WEEKS POST IMPLANT OF A REALIZE GASTRIC BAND WAS IN FOR THE FIRST FILL. THE PORT WAS ACCESSED UNDER FLUOROSCOPY AND THE SURGEON INJECTED 6-7 CC, HIS NORMAL PRACTICE IS TO FILL TO OCCLUSION AND THEN WITHDRAWS FLUID. HE WAS UNABLE TO WITHDRAW THE FLUID, DESPITE SEVERAL ATTEMPTS; HE COULD NOT ASPIRATE THE FLUID. THE PATIENT WAS TAKEN BACK TO THE OR TO EVALUATE FOR KINKING AS THE PORT WAS ACTING AS A ONE WAY VALVE. THE BAND AND TUBING WERE EXAMINED AND LOOKED FINE. THE SURGEON STATED THAT HE CUT DOWN TO THE PORT AND HE FOUND A LOT OF SCAR TISSUE. THE SCAR TISSUE WAS AROUND THE PORT CAUSING KINKING. THE SCAR TISSUE HAD TO BE CUT FROM AROUND THE TUBING. HE INDICATED THAT HE USES A SEPARATE PORT SITE AND 5MM TROCAR WHEN CONNECTING PORT TO TUBING. HE STATES THAT HE USES FASCIA CEPHALAD TO INSERT PORT. IN ADDITION, WHEN HE WAS REMOVING THE PORT, THERE WAS DIFFICULTY GETTING THE PORT OUT. HE HAD TO USE HEMOSTATS TO GET IT OFF. THE PORT WAS REPLACED. THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention