BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 2083106 · Received May 10, 2011

    Report

    Report Number
    3005992282-2011-00107
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 15, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A (B)(4) ADJUSTABLE GASTRIC BAND ((B)(4)), THE PATIENT HAD AN ATYPICAL INFECTION AROUND THE PROSTHESIS. THE ORIGINAL IMPLANT PROCEDURE PROCEEDED NORMALLY AND PATIENT WAS DISCHARGED DAY 2 POST OP. THE PATIENT HAD BEEN VERY ILL. THE PATIENT PRESENTED TO ANOTHER HOSPITAL WITH ABDOMINAL PAIN AND FEVER ON (B)(6) 2011. THE SCANS SHOWED GALLSTONES AND A DIAGNOSIS OF CHOLECYSTITIS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS (THE TYPE UNKNOWN) AND WAS DISCHARGED ON (B)(6) 2011. THE PATIENT WAS READMITTED ON (B)(6) 2011 WITH PAIN AND FEVER, CT SCANS SHOWED NOTHING UNUSUAL, PATIENT COULD NOT EAT OR DRINK. A LAPAROSCOPIC PROCEDURE WAS PERFORMED AND ON EXAMINATION A LARGE COLLECTION OF PUS AND FLUID WAS FOUND AROUND THE BAND. IT WAS REMOVED AND A SPECIMEN WAS COLLECTED. ON THE (B)(6) 2011, THE PATHOLOGY RESULTS RETURNED ATYPICAL BACTERIAL CONTAMINATION. THE PATHOLOGY WAS (B)(6), NON MULTI-RESISTANT (B)(6) AND (B)(6) INFECTION. ATYPICAL INFECTION MEANS IT IS FROM BACTERIA NOT NORMALLY ASSOCIATED WITH AN INFECTION IN THIS AREA. FOUR ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZLNBCY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention