BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISO FIBER

    MDR report key: 14137991 · Received April 18, 2022

    Report

    Report Number
    3006981798-2022-00008
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 18, 2022
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    PMA / PMN Number
    K100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED DURING MANUFACTURING AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. THE REPORT COULD NOT BE SUBSTANTIATED AND A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY FORM WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "WE HAD 3 SURGICAL SITE INFECTIONS OUT OF 3 DIDTS WITH THE SAME GERM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934766 ISO FIBER SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT RIVERPOINT MEDICAL LLC LIG-BN 21040141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other