BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-CP IMPLANT SET

    MDR report key: 4151936 · Received October 6, 2014

    Report

    Report Number
    9615741-2014-00046
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    September 11, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K093914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS CONCERNING THE SAME PATIENT. THIS REPORT CONCERNS UNI-CP IMPLANTS. IT WAS REPORTED "A PATIENT OF OURS HAD AN ALLERGIC REACTION TO THE INTEGRA QWIX AND UNI-CP HARDWARE. THE SURGEON WOULD LIKE YOU TO CONTACT HER AND GET HER ALL THE INFORMATION REGARDING THE HARDWARE AND EXACTLY WHAT EVERYTHING WAS MADE OUT OF. ON (B)(6) 2014, PATIENT STATED DEVICES WERE IMPLANTED IN HER LEFT FOOT ON (B)(6) 2013. PATIENT DEVELOPED 'FULL BODY HIVES' ALMOST IMMEDIATELY THAT LASTED UNTIL (B)(6) 2014 WHEN ALL THE HARDWARE WAS REMOVED. PATIENT HAD A SURGERY IN (B)(6) 2014. ALL HARDWARE WAS REMOVED AND NEW HARDWARE WAS INSERTED IN HER LEFT FOOT. ON (B)(6) 2014, HARDWARE WAS REMOVED AGAIN AND HIVES HAVE RESOLVED. ABOUT 95%. FROM OPERATIVE REPORT: (B)(6) 2014, 'PROBABLE ALLERGIC REACTION TO RETAINED HARDWARE LEFT FOOT' PATIENT REPORTED SHE HAD 10 SCREWS AND 2 PLATES IN HER POSSESSION THAT CAN BE RETURNED TO INTEGRA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622534 UNI-CP IMPLANT SET NA HRS NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention