BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1823810 · Received September 2, 2010

    Report

    Report Number
    3005992282-2010-00262
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 13, 2010
    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

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT.INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND/BALLOON SUB-ASSEMBLY WITH 41.5 CM OF CATHETER, THE INJECTION PORT WITH SUTURES AND THE LOCKING CONNECTOR WITH 3.5 CM OF CATHETER WERE RETURNED FOR ANALYSIS. A CUT WAS OBSERVED AT 10 CM FROM THE BAND STRAIN RELIEF, PROBABLY FROM BAND EXPLANT. THE PORT WAS RETURNED IN UNLOCKED POSITION, WITH 3 SUTURES AND SURGICAL GAUZE. ONE PUNCTURE WAS OBSERVED ON THE SEPTUM. THE LOCKING CONNECTOR WAS CORRECTLY CONNECTED TO THE PORT. BLOODSTAINS WERE OBSERVED ON THE BAND/BALLOON/CATHETER SUB-ASSEMBLY. BIOLOGICAL DEBRIS WAS OBSERVED ON THE PORT. THE COMPLAINT CANNOT BE CONFIRMED, THE PRODUCT ANALYSIS CANNOT CONFIRM THE BAND EROSION EVENT. BAND EROSION IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE REALIZE BAND. A DHR REVIEW WAS CONDUCTED AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED POST IMPLANT OF A REALIZE BAND, THE PATIENT WAS COMPLAINING ABOUT DYSPHAGIA. FIRST FILL ON (B)(6), 2010 WAS 4.5 CC, WHICH CAUSED DYSPHAGIA, SO THE BAND WAS DEFLATED TO 2 CC. THE BAND WAS EVENTUALLY COMPLETELY DEFLATED DUE TO DYSPHASIA. THE BAND WAS DETERMINED TO HAVE ERODED INTO THE PATIENT'S STOMACH. GASTROSTOMY WAS PERFORMED TO REMOVE THE BAND FROM THE PATIENT. SUTURES WERE USED TO CLOSE THE GASTROSTOMY. PATIENT WAS HOSPITALIZED FOR REMOVAL OF BAND, DISCHARGED ON POSTOP DAY 3. THERE WAS NO FURTHER PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRATIC THYROID-UPTAKE (T-UPTAKE) AND TOTAL THYROXINE (TT4) RESULTS FOR ONE PATIENT'S SAMPLE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED RESULTS BELOW THE NORMAL REFERENCE RANGE FOR BOTH ASSAYS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 ZKLBCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention