BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2780364 · Received October 5, 2012

    Report

    Report Number
    2024601-2012-01051
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    November 15, 2011
    Report Date
    September 10, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED. 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. BAND SLIPPAGE, NECROSIS, HEMORRHAGE, PAIN, NAUSEA AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF BAND SLIPPAGE AS FOLLOWS: "BAND SLIPPAGE AND/OR POUCH DILATATION CAN OCCUR. GASTROESOPHAGEAL REFLUX, NAUSEA AND/OR VOMITING WITH EARLY OR MINOR SLIPPAGE MAY BE SUCCESSFULLY RESOLVED BY BAND DEFLATION IN SOME CASES. MORE SERIOUS SLIPPAGES MAY REQUIRE BAND REPOSITIONING AND/OR REMOVAL. IMMEDIATE RE-OPERATION TO REMOVE THE BAND IS INDICATED IF THERE IS TOTAL STOMA-OUTLET OBSTRUCTION THAT DOES NOT RESPOND TO BAND DEFLATION OR IF THERE IS ABDOMINAL PAIN." "CAUTION: OVER-DISSECTION OF THE STOMACH DURING PLACEMENT MAY RESULT IN SLIPPAGE OR EROSION OF THE BAND AND REQUIRE REOPERATION." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF NECROSIS AS FOLLOWS: THERE WERE ADDITIONAL OCCURRENCES OF THOSE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ESOPHAGITIS, GASTRITIS, HIATAL HERNIA, PANCREATITIS, ABDOMINAL PAIN, HERNIA, INCISIONAL INFECTION, INFECTION, REDUNDANT SKIN, DEHYDRATION, GI PERFORATION, DIARRHEA, ABNORMAL STOOLS, CONSTIPATION, FLATULENCE, DYSPEPSIA, ERUCTATION, CARDIOSPASM, HEMATEMESIS, ASTHENIA, FEVER, CHEST PAIN, INCISION PAIN, CONTACT DERMATITIS, ABNORMAL HEALING, EDEMA, PARESTHESIA, DYSMENORRHEA, HYPOCHROMIC ANEMIA, BAND LEAK, CHOLECYSTITIS, ESOPHAGEAL DYSMOTILITY, ESOPHAGEAL ULCER, ESOPHAGITIS, PORT DISPLACEMENT, PORT SITE PAIN, SPLEEN INJURY, AND WOUND INFECTION. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HEMORRHAGE AS FOLLOWS: "ADVERSE EVENTS: SPECIFIC COMPLICATIONS OF LAPAROSCOPIC SURGERY CAN INCLUDE SPLEEN DAMAGE (SOMETIMES REQUIRING SPLENECTOMY) OR LIVER DAMAGE, BLEEDING FROM MAJOR BLOOD VESSELS, LUNG PROBLEMS, THROMBOSIS, AND RUPTURE OF THE WOUND."DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "THERE WERE ADDITIONAL OCCURRENCES OF THESE EVENTS THAT WERE CONSIDERED TO BE NON-SERIOUS. OTHER ADVERSE EVENTS CONSIDERED RELATED TO THE LAP-BAND SYSTEM THAT OCCURRED IN FEWER THAN 1% OF SUBJECTS INCLUDED: ABDOMINAL PAIN, CHEST PAIN, INCISION PAIN AND PORT SITE PAIN." DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF NAUSEA AND VOMITING AS FOLLOWS: "NAUSEA AND VOMITING MAY OCCUR, PARTICULARLY IN THE FIRST FEW DAYS AFTER SURGERY AND WHEN THE PATIENT EATS MORE THAN RECOMMENDED. NAUSEA AND VOMITING MAY ALSO BE SYMPTOMS OR STOMA OBSTRUCTION OR A BAND/STOMACH SLIPPAGE.

    Description of Event or Problem · 1

    REPORTED EVENTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, INTERNAL BLEEDING, PROLAPSED STOMACH, TISSUE DEATH, AND SURGICAL REMOVAL OF STOMACH FROM AN ARTICLE IN (B)(6) NEWSPAPER ENTITLED, "(B)(6)", PUBLISHED ON (B)(4) 2012.

    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 43 YR Hospitalization| R