BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGA

    MDR report key: 9214952 · Received October 21, 2019

    Report

    Report Number
    3012164473-2019-00027
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    October 16, 2019
    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 · 1

    RECORD REPRESENT 2:3 PATIENTS INVOLVED WITH ISSUE SAMPLE. THERE IS A PENDING VOLUNTARILY ELECTED RECALL FOR LOT# 190123-59 DUE TO ITS FAILURE TO MEET USP TENSILE STRENGTH SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE SNAPPED EASILY AND KNOTS WERE NOT HOLDING. (LOT# 190123-59) THREE PATIENTS SUBSEQUENTLY EXPERIENCED DEHISCENCE OF WOUNDS. THE CLINIC HAS BEEN CONTACTED MULTIPLE TIMES IN ATTEMPT TO RETRIEVE INFORMATION REGARDING EACH PATIENT'S EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010835 PGA POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE GAM CP MEDICAL 494A 190123-59 10790986000657

    Patients

    Seq Age Sex Outcome Treatment
    1