BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEPHAFLEX MESH

    MDR report key: 2799693 · Received October 17, 2012

    Report

    Report Number
    3005670760-2012-00001
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 17, 2012
    Manufacturer
    TEPHA INCORPORATED
    Product Code
    OOD
    PMA / PMN Number
    K113723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS FOR LOT 110311 WERE REVIEWED AND THERE IS NO EVIDENCE TO SUGGEST THE DEVICES MAY HAVE BEEN RELEASED WITH NONCONFORMITIES RELATED TO THE NATURE OF THIS EVENT. A VERY SMALL PIECE OF MESH WAS RETURNED OF LESS THAN 1CM, WHICH WAS TOO SMALL TO EVALUATE. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE PT ATTENDED A FOLLOW-UP VISIT ON (B)(6) 2012, APPROX 3 WEEKS AFTER THE INTERVENTION AT WHICH TIME THE SURGEON RECORDED THAT THE SURGICAL INCISION SITE WAS INTACT AND THERE WAS NO ERYTHEMA. THE PHYSICIAN CONSIDERS THIS ADVERSE EVENT TO BE RESOLVED.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED A SMAS SURGICAL PROCEDURE ON (B)(6) 2012. SEVEN MONTHS POST-PROCEDURE, THE PT RETURNED TO THE PHYSICIAN¿S OFFICE WITH A REDDENED AREA THAT WAS PAINFUL TO THE TOUCH. UPON EXAMINATION IT WAS FOUND THAT APPROXIMATELY 1CM MESH WAS EXTRUDING WITH INDICATIONS OF INFECTION. ALTHOUGH THE INFECTION WAS NOT CONFIRMED WITH CULTURES, THE PHYSICIAN PRESCRIBED A 7 DAY CYCLE OF DOXYCYCLINE FOR THE INFECTION. THE INCISION WAS REOPENED, CLEANED, AND RE-CLOSED AT THE ORIGINAL SURGICAL SITE. A DAY AFTER THE VISIT ON (B)(6) 2012, THE PHYSICIAN NOTED THAT THE PT HAD LESS PAIN, LITTLE REDNESS, AND THE WOUND LOOKED GOOD. ON (B)(6) 2012, THE PHYSICIAN NOTED THE PT AS BEING SIGNIFICANTLY BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEPHAFLEX MESH MESH, SURGICAL OOD TEPHA INCORPORATED 110311

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention