BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMATRIX FENESTRATED 4 X 4CM

    MDR report key: 10281043 · Received July 15, 2020

    Report

    Report Number
    3004170064-2020-00006
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Report Date
    June 17, 2020
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    KGN
    PMA / PMN Number
    K131286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRIMATRIX FENESTRATED WAS NOT RETURNED FOR EVALUATION THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    2 OF 2 REPORTS. SAME FAILURE. DIFFERENT PATIENTS. OTHER MFG REPORT NUMBER: 3004170064-2020-00005. A PHYSICIAN REPORTED SHE FELT THE PRIMATRIX DISSOLVED AND DID NOT ACHIEVE THE HEALING RESULTS THAT SHE PREVIOUSLY EXPERIENCED WITH OTHER PATIENTS/APPLICATIONS. THE PRODUCT WAS USED FOR MOHS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738480 PRIMATRIX FENESTRATED 4 X 4CM PRIMATRIX KGN TEI BIOSCIENCES INC 1903050

    Patients

    Seq Age Sex Outcome Treatment
    1