BEUDAMED
    FDA Adverse Event Other Summary report: N

    PMT INTEGRA TISSUE EXPANDER

    MDR report key: 2508510 · Received March 21, 2012

    Report

    Report Number
    2182979-2011-00004
    Event Type
    Other
    Date Received
    March 21, 2012
    Date of Event
    February 11, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PMT CORP.
    Product Code
    LCJ
    PMA / PMN Number
    K845036
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COPIED FROM THE 3/14/2012 FAX: PMT CONTACTED THE USER FACILITY FOR RETURN OF THE DEVICE, THEY HAVE NOT RESPONDED TO OUR REQUESTS. PMT CONDUCTED AN INVESTIGATION INTO THE STERILITY TESTING REPORTS RECEIVED BY (B)(4) FOR BOTH LOTS IN QUESTION ("LEFT" BREAST EXPANDER LOT 070110 EXP: 2014-07A). ALL BIOLOGICAL INDICATORS TESTED, TESTED NEGATIVE. TWO STERILE RUNS OF PRODUCT THROUGH PMT'S ETO STERILIZATION PROCESS WAS PROVEN STERILE VIA 59 SELF CONTAINED BIOLOGICAL INDICATOR CAPSULES THAT WERE TESTED FOR STERILITY, FOR THE RUNS IN WHICH THE PRODUCT WAS A PART OF. PMT FEELS THAT THE STERILE OPERATING FIELD MAY HAVE BEEN COMPROMISED DUE TO THE FACT THAT PMT HAS HAD NO NEGATIVE TRENDS REGARDING ANY PRODUCT THAT WAS SENT THROUGH THE 2 STERILITY RUNS IN QUESTION. COPIED FROM THE 3/14/2012 FAX - 3RD PAGE: PER THE MEDWATCH RECEIVED BY PMT CORPORATION ON (B)(6) 2011, THE FOLLOWING TESTS WERE CONDUCTED AT THE HOSPITAL. PATHOLOGY REPORT: (B)(6) 2011, LABELED "LEFT BREAST TISSUE EXPANDER. THERE IS A SCANT AMOUNT OF ADHERENT YELLOW, MARKEDLY SOFTENED NECROTIC SOFT TISSUE.

    Description of Event or Problem · 1

    THIS FORM IS THE SECOND OF THE TWO REQUESTED. COPIED FROM 3/14/2012 FAX: PMT CORPORATION RECEIVED A MEDWATCH FORM IN THE MAIL ON 02/24/2011. PMT INITIATED COMPLAINT (B)(4). AS DESCRIBED IN THE MEDWATCH THAT PMT CORPORATION RECEIVED, A PATIENT THAT UNDERWENT A BILATERAL MASTECTOMY ON (B)(6) 2011 WITH THE TISSUE EXPANDER INSERTED ON (B)(6) 2011. THE PATIENT DEVELOPED AN ELEVATED TEMP, PURULENT DRAINAGE AND CHEST WALL CELLULITIS, AND WAS ADMITTED TO THE OPERATING ROOM FOR IV ANTIBIOTICS ON (B)(6) 2011. THE TISSUE EXPANDER REMOVAL WAS CONDUCTED ON (B)(6) 2011. PRE AND POST OP DIAGNOSIS WAS BILATERAL INFECTED BREAST EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMT INTEGRA TISSUE EXPANDER INTEGRA TISSUE EXPANDER LCJ PMT CORP. 3611ES-552-2I (L) 070110

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention