BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT ADHESION REDUCTION SOLUTION

    MDR report key: 1953290 · Received January 7, 2011

    Report

    Report Number
    2954761-2011-00003
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    MCN
    PMA / PMN Number
    P050011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: ADEPT IS A STERILE 4% ICODEXTRIN SOLUTION THAN IS INSTILLED INTRAPERITONEALLY DURING SURGERY. AN INFECTION INDUCED BY ADEPT IS UNLIKELY; NEVERTHELESS, A POTENTIAL CAUSAL RELATIONSHIP CANNOT BE DETERMINED BASED ON THE CLINICAL DATA RECEIVED. FOR A MEDICAL ASSESSMENT FOLLOWING INFORMATION NEEDS TO BE CLARIFIED: LOT NUMBER; DATE OF SURGERY AND DATE OF OCCURRENCE OF INFECTION; TYPE OF SURGERY AND VOLUME OF ADEPT USED, INCLUDING DETAILS OF THE APPLICATION (BOTH IRRIGATION AND INSTILLATION; WHAT OTHER RISK FACTOR HAVE BEEN DETERMINED IN THE PATIENT (IMPLANT, DIABETES MELLITUS, CORTICOSTEROIDS, ETC.); CONCOMITANTLY USED MEDICATION, DRUGS OR MEDICAL DEVICES DURING SURGERY; POSTOPERATIVE COURSE; TYPE OF INFECTION (PERITONITIS, WOUND INFECTION, ETC.) AND LABORATORY PARAMETERS RELATED TO COMPLICATION INVESTIGATION; COURSE OF COMPLICATION. UPON RECEIPT OF THE CLINICAL INFORMATION A MEDICAL ASSESSMENT WILL BE PROVIDED. (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. BAXTER (B)(4) IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CASE DETAILS WERE REQUIRED TO DETERMINE IF A CAUSAL RELATIONSHIP BETWEEN THE USE OF THE PRODUCT AND REPORTED EVENT EXISTS. BAXTER (B)(6) HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL CASE DETAILS. NO RESPONSE WAS RECEIVED. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    REGISTRAR FROM (B)(6) HOSPITAL IN (B)(4) CALLED REP TO ADVISE THAT IN THE LAST 12 MONTHS, THEY HAVE HAD A SEVERE INFECTION REPORTED POSSIBLY DUE TO ADEPT. AS A RESULT, THEY HAVE STARTED TO AUDIT THEIR ADEPT PATIENTS. THE PATIENT NEEDED TO BE HOSPITALIZED WITH IV ANTIBIOTICS. REGISTRAR CALLED TO REQUEST CLINICAL DATA ON ADEPT AND INFECTION. REGISTRAR WOULD ALSO LIKE TO CONFIRM THAT THEY ARE USING CORRECT AMOUNT FOR PROCEDURES. SURGEON IS FAMILIAR WITH ADEPT AND IS USING ABOUT 3 BAGS PER WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEPT ADHESION REDUCTION SOLUTION BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE - VIENNA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other