BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 1884584 · Received October 19, 2010

    Report

    Report Number
    2024601-2010-00862
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER UNK. (B)(4). THE RPTR OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER. THE INFO HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO SERIAL NUMBER WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF DYSPHAGIA AND REFLUX AS FOLLOWS: "ULCERATION, GASTRITIS, GASTROESOPHAGEAL REFLUX, HEARTBURN, GAS BLOAT, DYSPHAGIA, DEHYDRATION, CONSTIPATION AND WEIGHT REGAIN HAVE BEEN REPORTED AFTER GASTRIC RESTRICTION PROCEDURES." DEVICE LABELING ADDRESSES THE REPORTED EVENT OF HERNIA 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: 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."

    Description of Event or Problem · 1

    RECEIVED A VOICEMAIL MESSAGE FROM HEALTH PROFESSIONAL REQUESTING A RETURN KIT FOR AN EXPLANTED DEVICE. IN THE MESSAGE, HEALTH PROFESSIONAL SAID THEY HAVE A DEVICE TO RETURN TO ALLERGAN. NO ADDITIONAL INFO WAS PROVIDED. DEVICE IS BEING RETURNED. FURTHER FOLLOW-UP: THE OFFICE REPORTED, "EXPLANTED GASTRIC BAND + PORT. (PATIENT) HAD 3CM HIATAL HERNIA ALONG (WITH) RECURRENT DYSPHAGIA AND REFLUX."

    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 37 YR