BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMATRIX

    MDR report key: 2492424 · Received March 9, 2012

    Report

    Report Number
    3004170064-2012-00003
    Event Type
    Other
    Date Received
    March 9, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 9, 2012
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    KGN
    PMA / PMN Number
    K083440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD FOR THIS PRODUCT LOT WAS REVIEWED AND EVERYTHING WAS FOUND TO BE IN ORDER INCLUDING ALL STERILITY INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE (B)(6) MALE PATIENT, WEIGHT (B)(6), HAD THE DEVICE (PRIMATRIX) APPLIED TO THE LEFT METATARSAL HEAD 1 DIABETIC FOOT ULCER. ON (B)(6) 2012, DURING HIS NEXT VISIT, THE GRAFT APPEARED TO HAVE TAKEN AND THE LEFT METATARSAL HEAD 1 ULCER APPEARED TO HAVE A HEALTHY WOUND BED AND ONLY SEROUS DRAINAGE. THE DRESSING WAS CHANGED AND THE PATIENT WAS SCHEDULED FOR HIS NEXT VISIT ON (B)(6) 2012. THE PATIENT BEGAN TO FEEL SICK TWO DAYS LATER AND WENT TO (B)(6) MEDICAL CENTER ER. THE INFECTION COULD NOT BE LOCALIZED TO THE WOUND OR THE METATARSAL AND AN MRI WAS NEGATIVE. THE INFECTION WAS FINALLY DIAGNOSED AS A (B)(6) AT THE DEEP SPACES IN THE LEFT LEG RESULTING IN A BELOW THE KNEE AMPUTATION WHEN IT DID NOT RESPOND TO ANTIBIOTICS. THE AMPUTATION TOOK PLACE ON (B)(6) 2012. THE AMPUTATED TISSUE INCLUDED THE DEVICE, THEREFORE, ALTHOUGH THE DEVICE HAD BEEN REMOVED FROM THE PATIENT, IT HAD NOT BEEN SPECIFICALLY EXPLANTED AND WAS NOT AVAILABLE FOR EVALUATION. THE PHYSICIAN STATED THAT, "THE UNDERLYING INFECTION DID NOT MANIFEST ITSELF UNTIL AFTER THE DEVICE WAS APPLIED. HE DID NOT BELIEVE THAT THE DEVICE OR THE PROCEDURE WAS THE CAUSATIVE AGENT FOR THE INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMATRIX WOUND DRESSING KGN TEI BIOSCIENCES INC. 607-005-044 1108036

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention