BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSWIFT

    MDR report key: 8213895 · Received January 3, 2019

    Report

    Report Number
    3012164473-2019-00012
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Report Date
    January 3, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986001388
    PMA / PMN Number
    K072229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS FOR UNKNOWN PATIENT 2:2 REFERENCE MFR REPORT # 3012164473-2019-00011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PGCL SUTURE ASSOCIATED WITH LOT# 180523-52 AND LOT# 180131-50 WERE BREAKING WHILE BEING TIED DOWN AND NEEDLE DETACHING AFTER INITIAL PASS. THIS FAILURE OCCURRED WITH 2 PATIENTS DURING ORAL SURGERY. THE PATIENTS DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7740 MONOSWIFT PGCL GAM CP MEDICAL L463 180131-50 10790986001388

    Patients

    Seq Age Sex Outcome Treatment
    1