BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT ADHESION REDUCTION SOLUTION

    MDR report key: 2923332 · Received January 22, 2013

    Report

    Report Number
    2032282-2013-00012
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    MCN
    PMA / PMN Number
    P050011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). DUE TO THE LACK OF INFORMATION, THE CASE IS NOT CURRENTLY ASSESSABLE AND THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER WAS NOTIFIED FROM THE CUSTOMER THAT HE DOES NOT HAVE ANY CONCERNS IN RELATION TO THE PRODUCT ADEPT AND THAT THE RAISED CRPS (C-REACTIVE PROTEIN) COULD BE EXPLAINED FROM THE PATIENT'S CONDITIONS AS THEY WERE COMPLEX IN NATURE. BAXTER MEDICAL ASSESSMENT: ACCORDING TO THE TREATING SURGEON THE RAISED CRPS AND WBC COULD BE EXPLAINED FROM THE PATIENT'S CONDITIONS AS THEY WERE COMPLEX IN NATURE. THE ADVERSE EVENT IS NOT RELATED TO THE USE OF ADEPT. CUSTOMER CLOSURE NOTIFICATION WILL BE COMPLETED PER LOCAL PROCEDURES AND REQUIREMENTS, IF APPLICABLE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A CASE THAT WAS REPORTED ON (B)(6) 2013 TO BAXTER (B)(4) FROM (B)(4) HOSPITAL. IT WAS REPORTED THAT A CONSULTANT SURGEON NOTICED THAT THE LAST 3 PATIENTS HE USED ADEPT 1.5L ON (BATCH UNKNOWN) ALL HAVE RAISED WCC (WHITE CELL COUNT) AND RAISED CRP'S (C-REACTIVE PROTEIN). THE ONLY COMMON DENOMINATOR AMONGST ALL THREE PATIENTS IS THAT ALL HAVE HAD ADEPT 1.5L USED LAPAROSCOPICALLY. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS IS ONE OF THE THREE REPORTS THAT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31273 ADEPT ADHESION REDUCTION SOLUTION BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE - VIENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other