BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT

    MDR report key: 6206707 · Received December 27, 2016

    Report

    Report Number
    3010097129-2016-00001
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    June 30, 2016
    Report Date
    December 27, 2016
    Manufacturer
    HARBOR MEDTECH, INC.
    Product Code
    KGN
    PMA / PMN Number
    K122502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LACK OF PATIENT AND PRODUCT INFORMATION, AND MOST IMPORTANTLY, ANY LABORATORY TESTING CONFIRMING BACTERIAL CONTAMINATION OF THE PRODUCT, THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND THUS NO ADDITIONAL TESTING COULD BE PERFORMED. REVIEW OF THE LOT RECORDS INDICATED THAT THE DEVICE MET ALL ACCEPTANCE CRITERIA INCLUDING STERILITY PRIOR TO RELEASE. WE ARE UNABLE TO CONFIRM THE ORIGIN OF THE INFECTION FROM THE TIME IN WHICH THE STERILE POUCH WAS OPENED TO THE TIME IN WHICH THE DEVICE WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT THE DEVICE WAS PLACED ON A PATIENT, WORKED "OK" BUT AT THE ONE-WEEK FOLLOW-UP VISIT HAD TO BE REMOVED DUE TO PSEUDOMONAS OVERGROWTH. THE GRAFT WAS PURPORTEDLY DISPOSED. MANUFACTURER CONTACTED PHYSICIAN WHO STATED THAT THE PATIENT DID "WELL", HAD NO INFECTION, AND THE DEVICE DID NOT HARM THE PATIENT. NO LABORATORY TESTS WERE PERFORMED. SUBSEQUENT ATTEMPTS, INCLUDING DIRECT WRITTEN INQUIRIES, WERE MADE TO OBTAIN PATIENT-LEVEL INFORMATION; HOWEVER, PHYSICIAN WAS EITHER UNWILLING OR UNABLE TO PROVIDE ADDITIONAL INFORMATION. WHEN ASKED TO PROVIDE SPECIFIC DETAIL ON THE PATIENT AND THE EVENT, THE PHYSICIAN RESPONDED, "THIS WAS NOT AN ADVERSE EVENT" AND HAS SINCE NOT RESPONDED TO FURTHER ATTEMPTS TO GAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855708 ARCHITECT COLLAGEN WOUND DRESSING KGN HARBOR MEDTECH, INC. HMT-036F-FX 036F160311B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention