BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2739371 · Received September 7, 2012

    Report

    Report Number
    2024601-2012-00808
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 8, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. MEDWATCH SENT TO FDA ON: (B)(4) 2012. F/U WITH THE AUTHORS OF THE ABSTRACT IS NOT POSSIBLE SINCE NO CONTACT INFO WAS PROVIDED; THEREFORE, WE WERE UNABLE TO REQUEST RETURN OF THE DEVICE. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YRS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SURGERY RELATED COMPLICATION/OBSERVATION AS FOLLOWS: "COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE SURGICAL PROCEDURE, THE RISKS ASSOCIATED WITH ANY SURGICAL PROCEDURE AND THE PT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IMPLANTED IN THE BODY."

    Description of Event or Problem · 1

    ABSTRACT RECEIVED FROM ALLERGAN IRVINE, GLOBAL LITERATURE AND INFO SERVICES, THROUGH SPECIAL "PRODUCT WATCH"; OBES SURG (2012) 22:1144-1205 O-027 "LAPAROSCOPIC ADJUSTABLE BANDED ROUX-EN-Y GASTRIC BYPASS AS A PRIMARY PROCEDURE FOR THE SUPER-OBESE: FIRST CASES", (B)(6)." ABSTRACT MENTIONED: "THERE WERE NO MORTALITIES, SHORT-TERM MORBIDITY WAS LIMITED TO ONE PT WITH POSTOPERATIVE PNEUMONIA". ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention