BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALASHAPE 3D

    MDR report key: 7024153 · Received November 13, 2017

    Report

    Report Number
    3005670760-2017-00014
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    June 24, 2017
    Report Date
    October 4, 2017
    Manufacturer
    TEPHA, INC.
    Product Code
    OOD
    UDI-DI
    00855920006217
    PMA / PMN Number
    K140533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE OF (B)(6) 2017, EXPLANT DATE ON (B)(6) 2017; PHYSICIAN PERFORMED A CULTURE OF THE INFECTED TISSUE AND CONFIRMED GROWTH OF PSEUDOMONAS AERUGINOSA. REVIEW OF DHR (DEVICE HISTORY RECORD) ON PART NUMBER 100042-04, LOT NUMBER 170060 RESULTED IN VERIFICATION THAT THERE WERE NO NON-CONFORMITIES (NCR) DOCUMENTED FOR THIS LOT OF GALASHAPE 3D. THE STERILIZATION CYCLE REPORT WAS REVIEWED AND THE CYCLE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    PATIENT DEVELOPED ABSCESS 11 WEEKS POST OPERATIVELY REQUIRING IMPLANT AND MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804287 GALASHAPE 3D GALAFLEX MESH, PRODUCT CODE: OOD OOD TEPHA, INC. 10042-04 170060 00855920006217

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention