BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN

    MDR report key: 2140951 · Received June 21, 2011

    Report

    Report Number
    1121308-2011-00019
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTED STATED THAT THE PT HAD SURGERY ON (B)(6) 2011 FOR A LEFT DORSAL WRIST MASS. THE PROCEDURES WERE DORSAL WRIST GANGLIONECTOMY, WRIST JOINT CAPSULORRHAPHY, AND WRIST JOINT SYNOVECTOMY. ON (B)(6) 2011, THE PT COMPLAINED OF A LARGE BUMP ON THE LEFT HAND AT THE INCISION SITE, WITH NUMBNESS OF THE KNUCKLES, AND INABILITY TO FLEX OR EXTEND, AND HEAT AT THE SITE. HEMATOMA WAS DIAGNOSED AND ASPIRATION WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. ON (B)(6) 2011, THE PT COMPLAINED OF RETURN OF THE GANGLION CYST ON HER HAND. THE MASS WAS ON THE TENDON THAT WAS EXCISED AND WHERE TENOGLIDE WAS PLACED OVER THE TENDONS. ON (B)(6) 2011, REVISION SURGERY WAS PERFORMED. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN TENOGLIDE JXI INTEGRA, PLAINSBORO 105A00193691

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other PROPHYTACTIC ANTIBIOTICS| MARCAINE DIGITAL BLOCKS