BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGA

    MDR report key: 9470122 · Received December 13, 2019

    Report

    Report Number
    3012164473-2019-00035
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Report Date
    January 16, 2020
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986000657
    PMA / PMN Number
    K002190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT AMENDED TO REFLECT TEST RESULTS OF ISSUE SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED SIZE 4/0 PGA SUTURE BEING WEAK AND FRAYING UPON USE. (LOT# 190425-51) THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE SURGERY WASN'T DELAYED GREATER THAN 30 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED SIZE 4/0 PGA SUTURE BEING WEAK AND FRAYING UPON USE. (LOT# 190425-51) THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE SURGERY WASN'T DELAYED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264875 PGA POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE GAM CP MEDICAL 494A-CP1 190425-51 10790986000657

    Patients

    Seq Age Sex Outcome Treatment
    1