BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMID

    MDR report key: 17878937 · Received October 5, 2023

    Report

    Report Number
    3012164473-2023-00004
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    March 9, 2022
    Report Date
    October 5, 2023
    Manufacturer
    CP MEDICAL
    Product Code
    GAR
    UDI-DI
    10790986002521
    PMA / PMN Number
    K001173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING PART NUMBER 1669B LOT 200115-54, SIZE 3/0 BLACK NYLON (NYL BLA SWAGE SUTURE. THE CUSTOMER STATED THAT THE SUTURES HAD NO TENSILE STRENGTH AND WOULD EASILY BREAK JUST BY INSERTING THE SUTURE THROUGH THE SKIN. THE CUSTOMER FURTHER STATED THAT MANY SURGERIES WERE PERFORMED, AND THAT BREAKAGES OCCURRED DURING PROCEDURES. ACCORDING TO THE CUSTOMER, MOST WERE FOR CLOSING OFF INCISIONS. THE PROVIDER MENTIONED SEVERAL PATIENTS INVOLVED, BUT AN ACTUAL COUNT WAS NOT PROVIDED; THERE WERE NO REPORTS OF DELAYS IN THE PROCEDURES GREATER THAN 30 MINUTES. NO FURTHER INFORMATION WAS OBTAINED FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009996 MONOMID NYLON SURGICAL SUTURE, PRODUCT GAR CP MEDICAL 1669B 200115-54 10790986002521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other