BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONO Q

    MDR report key: 25194128 · Received May 15, 2026

    Report

    Report Number
    3009681798-2026-00021
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 15, 2026
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAM
    UDI-DI
    00810020087659
    PMA / PMN Number
    K100461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED UNDER COMPLAINT (B)(4). TWO AFFECTED UNITS WERE REPORTED FROM LOT 24090603. A SEPARATE COMPLAINT INVOLVING THE SAME MALFUNCTION MODE FROM LOT 25052102 IS BEING EVALUATED UNDER A SEPARATE MDR 3009681798-2026-00022. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. NO NONCONFORMITIES WERE NOTED DURING PRODUCTION AND ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. RETAIN SAMPLES FROM THE AFFECTED LOT WERE EVALUATED AND PASSED ALL APPLICABLE TESTING REQUIREMENTS. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE COMPLAINT COULD NOT BE SUBSTANTIATED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA FORM 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS SUBMITTED THIS REPORT IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENTS OF 21 CFR PART 803. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "WE RECEIVED A COMPLAINT FROM OUR CUSTOMER REGARDING THE SUTURE BEING OFF THE NEEDLE ON TWO UNITS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494292 MONO Q (POLIGECAPRONE 25) VIOLET MONOFILAMENT SUTURE GAM RIVERPOINT MEDICAL LLC Q392 24090603 00810020087659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown