BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASS LP

    MDR report key: 7922601 · Received October 1, 2018

    Report

    Report Number
    1000432246-2018-00016
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 15, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K100297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT BENT DOWN TO PICK UP A ROCK AND FELT A "POP" IN HIS BACK. HE HAS CONSIDERABLE LOW BACK PAIN, BUT NO OTHER INJURIES. PATIENT WILL BE REVISED ON (B)(6) 2018. (B)(4). EXEMPTION E2017030.

    Description of Event or Problem · 0

    THE PATIENT BENT DOWN TO PICK UP A ROCK AND FELT A "POP" IN HIS BACK. HE HAS CONSIDERABLE LOW BACK PAIN, BUT NO OTHER INJURIES. PATIENT WILL BE REVISED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765634 PASS LP UNID ROD MNI MEDICREA INTERNATIONAL OUV7DJUT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention