BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANALOC LOOP RC ANCHOR

    MDR report key: 1870200 · Received October 11, 2010

    Report

    Report Number
    1221934-2010-00347
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT POST ROTATOR CUFF REPAIR WITH THE USE OF 2 PANALOC LOOP RC ANCHORS FOR FIXATION, PSEUDOMONAS INFECTION WAS DETECTED VIA POSITIVE CULTURES INDICATING ALSO THAT THE BACTERIA IS GRAM NEGATIVE; NORMAL RESIDENT BACTERIUM. THE FACILITY IS INVESTIGATING ALL POSSIBILITIES TO TRY AND DETERMINE THE UNDERLYING CAUSE OF THIS ISSUE. THIS IS ALL OF THE INFO THAT HAS BEEN MADE AVAILABLE TO MITEK TO DATE. ALSO SEE ASSOCIATED MDR 1221934-2010-00348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANALOC LOOP RC ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 210702 3382630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention