BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE FELT PLEDGETS

    MDR report key: 14998909 · Received July 13, 2022

    Report

    Report Number
    2020394-2022-00578
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    November 5, 2016
    Report Date
    June 22, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. CHLOE DUMOT, ANDREI BRINZEU, JULIEN BERTHILLER, MARC SINDOU (2016). TRIGEMINAL NEURALGIA DUE TO VENOUS NEUROVASCULAR CONFLICTS: OUTCOME AFTER MICROVASCULAR DECOMPRESSION IN A SERIES OF 55 CONSECUTIVE PATIENTS. ACTA NEUROCHIRURGICA, 159:237¿249. DOI 10.1007/S00701-016-2994-Y. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE "DUMOT 2017_TRIGEMINAL NEURALGIA DUE TO VENOUS NEUROVASCULAR CONFLICTS OUTCOME AFTER MICROVASCULAR DECOMPRESSION IN A SERIES OF 55 CONSECUTIVE PATIENTS" THAT POST MICROVASCULAR DECOMPRESSION SURGICAL PROCEDURE, THE SUBJECT DEVELOPED A NERVE DAMAGE. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702635 PTFE FELT PLEDGETS SURGICAL OTHER DXZ BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other