BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3007966929-2022-00032

    MDR report key: 15939334 · Received December 8, 2022

    Report

    Report Number
    3007966929-2022-00032
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Report Date
    December 1, 2022
    Manufacturer
    UNOMEDICAL ZAVODSKAYA STREET 50
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: OP-FLEX SET POOLE X-RAY/350. COMMON DEVICE NAME: CATHETER AND TIP, SUCTION. PROCODE: JOL. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "HAIR IN PACKAGE." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585522 JOL UNOMEDICAL ZAVODSKAYA STREET 50 34071182 349888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown