BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNDEFINED PANALOK ANCHOR

    MDR report key: 1212575 · Received October 24, 2008

    Report

    Report Number
    1221934-2008-00496
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    October 17, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME THIS ISSUE IS BASICALLY ONGOING. WE ARE IN THE PROCESS OF GATHERING FURTHER DETAILED INFORMATION; PATIENT STATUS, DIAGNOSIS, COURSE OF ACTION, ROOT CAUSE, ETC. WHEN ALL THAT CAN BE HAD IS HAD AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    WE RECEIVED A CALL FROM A MALE PATIENT. HE, THE PATIENT, IS REPORTING THAT HE IS HAVING A REACTION THAT HE BELIEVES MAY BE RELATED TO AN ELBOW SURGERY WITH THE USE OF 2 UNKNOWN PANALOK ANCHORS FOR FIXATION THAT HE HAD THIS YEAR. 5 DAYS POS-OP AN ITCHY RASH APPEARS ALL OVER HIS BODY. HE CONSULTED WITH HIS PCP, WHO PRESCRIBED AN ANTIHISTAMINE, WHICH COMPLETELY ABATED THE RASH AND ITCHINESS. HOWEVER, WHEN THE PATIENT'S PRESCRIPTION RAN OUT, THE RASH RESURFACED. THE PCP PUT HIM ON BENADRYL, THE RASH WAS FOR AWHILE INTERMITTENT BUT IS NOW EVERYDAY. THE PATIENT WAS REFERRED TO A DERMATOLOGIST, AT WHICH TIME THE DERMATOLOGIST ADMINISTERED A "PATCH TEST" (?) ON HIS BACK. THE PATIENT WAS RETURNING TO THE DERMATOLOGIST TODAY, FOR THE RESULTS OF THE PATCH TEST. AT THIS POINT IN TIME THE PATIENT WAS TOLD THAT HE WOULD BE CONTACTED BY SOMEONE IN QUALITY IN THE NEAR FUTURE TO GATHER FURTHER DETAILS. ALSO SEE ASSOCIATED MDR 1221934-2008-00495.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNDEFINED PANALOK ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR