BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISORB QUICK

    MDR report key: 8723024 · Received June 21, 2019

    Report

    Report Number
    3012164473-2019-00016
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    November 6, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986004112
    PMA / PMN Number
    K023710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT AMENDED TO REFLECT TEST RESULTS FROM ISSUE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED POLYGLYCOLIC ACID FAST ABSORBING SUTURE BROKE WHILE STITCHING A PATIENT. (LOT# 190213-56) THE EVENT OCCURRED DURING SKIN SURGERY BUT DID NOT CAUSE A DELAY IN PROCEDURE. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED POLYGLYCOLIC ACID FAST ABSORBING SUTURE BROKE WHILE STITCHING A PATIENT. (LOT# 190213-56) THE EVENT OCCURRED DURING SKIN SURGERY BUT DID NOT CAUSE A DELAY IN PROCEDURE. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518835 VISORB QUICK POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE GAM CP MEDICAL VQ493 190213-56 10790986004112

    Patients

    Seq Age Sex Outcome Treatment
    1