BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISSECTOR CEV531-3 DIA 5MM LRG CVD

    MDR report key: 8678370 · Received June 7, 2019

    Report

    Report Number
    2523190-2019-00074
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 16, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED; HOWEVER, THE EVALUATION DID NOT CONCLUSIVELY VERIFY THE COMPLAINT AS VALID. DHR FOR LOT NO. 1687398 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE DEVICE PASS THE ELECTRICAL TEST. AN INVESTIGATION FOR ROOT CAUSE WAS UNABLE TO BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER: 2523190-2019-00073 AND 2523190-2019-00075.

    Description of Event or Problem · 1

    2 OF 3 REPORTS. IT WAS REPORTED THAT ON (B)(6) 2019, THE DOCTOR WAS USING THE CEV531-3 DISSECTOR DIA 5 MM LRG CVD FOR AN UNSPECIFIED PROCEDURE, AND A FEMALE PATIENT WAS BURNT. THE EVENT DID NOT LEAD TO AN INCREASE IN THE SURGERY TIME. ADDITIONAL REQUEST FOR INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474195 DISSECTOR CEV531-3 DIA 5MM LRG CVD PFM16 GEI INTEGRA MICROFRANCE S.A.S. 1687398

    Patients

    Seq Age Sex Outcome Treatment
    1 CEV515M FORCEPS| CEV525M FORCEPS| CEV515M FORCEPS| CEV525M FORCEPS