BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT

    MDR report key: 2223738 · Received August 25, 2011

    Report

    Report Number
    2954761-2011-00049
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    MCN
    PMA / PMN Number
    P050011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED NOTIFICATION FROM BAXTER ARGENTINA THAT THE SURGEON HAS BEEN PROVIDED WITH INFORMATION REGARDING PRECAUTIONS PER THE INSTRUCTIONS FOR USE. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    VOLUNTARY REPORT NUMBER: (B)(4). BAXTER MEDICAL ASSESSMENT: WHILE THE USE OF ADEPT (4% ICODEXTRIN) IS NOT CONTRAINDICATED FOR USE TO PREVENT ADHESION IN THIS TYPE OF SURGERY, THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE ARE CAUTIONING THE USERS IN PROCEDURES INVOLVING BOWEL RESECTION OR REPAIR AGAINST THE POTENTIAL OCCURRENCE OF ANASTOMOTIC FAILURES, ILEUS AND PERITONITIS. THE REPORTED COMPLICATION OF AN ANASTOMOTIC DEHISCENCE AND THE SUBSEQUENT SUBPHRENIC ABSCESS ARE MOST COMMONLY THE RESULT OF SURGERY AND SURGICAL TECHNIQUE, AND ARE KNOWN COMPLICATIONS OF THIS TYPE OF SURGERY, WE CANNOT EXCLUDE THAT ADEPT HAS CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. A DOCUMENTED REVIEW OF THE ADEPT INSTRUCTIONS FOR USE - ESPECIALLY OF THE PRECAUTIONS SECTION SPECIFICALLY REFERRING TO ITS USE IN BOWEL REPAIR SURGERY - IS RECOMMENDED. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF REVIEWING THE INSTRUCTIONS FOR USE FOR ADEPT WITH THE SURGEON.

    Description of Event or Problem · 1

    THE SURGEON THAT PERFORMED THE SURGERY INFORMED THAT A DEHISCENCE OF THE COLONIC SIGMOID ANASTOMOSIS AND SUBPHRENIC ABCESS WAS PRESENTED IN THE PATIENT. DATE OF EVENT IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other