BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGA

    MDR report key: 9454660 · Received December 11, 2019

    Report

    Report Number
    3012164473-2019-00031
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986000473
    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 3/0 PGA SUTURE BREAKING DURING PROCEDURE. (LOT# 190312-53). THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250219 PGA POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE GAM CP MEDICAL 423A-CP1 190312-53 10790986000473

    Patients

    Seq Age Sex Outcome Treatment
    1