BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMATRIX

    MDR report key: 7326993 · Received March 8, 2018

    Report

    Report Number
    MW5075762
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    March 15, 2017
    Report Date
    March 7, 2018
    Manufacturer
    TEI BIOSCIENCES
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SALES REP PRESENT IN THE SURGERY ROOM SOLD A PRODUCT CALLED PRIMATRIX TEI BIOSCIENCES TO BE USED TO CLOSE A FASCIA DEFECT IN SOMEONE WITH SUSPECTED CHRONIC EXERTIONAL COMPARTMENT SYNDROME IN WHICH THE COMPANY MANUFACTURER WEBSITE CLAIMS IT WAS NOT MEANT TO BE SOLD EXCEPT AS A SKIN GRAFT TO BE USED ON THE SKIN FOR WOUND HEALING AND THAT IS ENTIRELY CONTRAINDICATED FOR THE CONDITION. THE PRODUCT WASN'T SUPPOSED TO BE SOLD. THERE WAS NO CONSENT VIA CONSENT FORM FOR THE IMPLANT AND IT WAS CONTRAINDICATED FOR THE PRESENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168046 PRIMATRIX PRIMATRIX FRO TEI BIOSCIENCES LOG446568 1509057

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| O| S MULTIVITAMIN. | OTC MEDS: MAGNESIUM| RX MEDS: NONE.