BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN AP STANDARD LAP BAND

    MDR report key: 1852949 · Received September 28, 2010

    Report

    Report Number
    MW5017645
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 8, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MORBIDLY OBESE FEMALE UNDERWENT INSERTION OF GASTRIC LAP BAND (B)(6)2010. PRESENTED TO ED (B)(6)2010 WITH COMPLAINT OF FEVER-TMAX 106- AND VOMITING; UNDERWENT EXTENSIVE WORKUP, HOWEVER COULD NOT FIND SOURCE OF FEVER AND OTHER COMPLICATIONS. BAND IN PROPER POSITION WITH NO LEAK NOTED; POSSIBILITY OF ALLERGY TO LAP BAND EXPLORED AND PATIENT TAKEN TO OPERATING ROOM FOR REMOVAL. STORMY POST-OP COURSE, HOWEVER, REMAINED AFEBRILE AFTER REMOVAL. AL1 INTRA-OPERATIVE CULTURES NEGATIVE. DISCHARGED HOME (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN AP STANDARD LAP BAND GASTRIC LAP BAND LTI ALLERGAN REF: B-2240

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other