BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGA

    MDR report key: 9454659 · Received December 11, 2019

    Report

    Report Number
    3012164473-2019-00029
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986000381
    PMA / PMN Number
    K002190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED SIZE 4/0 PGA SUTURE BREAKING DURING NORMAL PROCEDURE. (LOT# 181017-60). THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250200 PGA POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE, GAM CP MEDICAL 392A 181017-60 10790986000381

    Patients

    Seq Age Sex Outcome Treatment
    1