BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY CHECK FETAL SCALP BLOOD SAMPLER KARL STORZ SE

    MDR report key: 11797125 · Received May 7, 2021

    Report

    Report Number
    MW5101257
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 6, 2021
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    HGK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FETAL SCALP BLOOD SAMPLER FROM KARL STORZ SE. AS CLINICAL REVIEWER I FOUND OUT THAT THE RISK ASSOCIATED WITH THAT PRODUCT NO LONGER JUSTIFY THE BENEFITS, IF ANY BENEFIT AT ALL. THE MANUFACTURER SUBMITTED A CLINICAL EVALUATION FOR THREE YEARS, IGNORING THE CLINICAL DATA WITHOUT PROVIDING ACTION, WHICH LET TO FURTHER CASES. I NEED TO PROVIDE THE AGENCY WITH MY REPORT, SO 4000 CHARACTER ARE NOT SUFFICIENT, PROVIDE AN EMAIL TO REPORT THAT CASE ADEQUATELY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684833 EASY CHECK FETAL SCALP BLOOD SAMPLER KARL STORZ SE ENDOSCOPE, FETAL BLOOD SAMPLING (AND ACCESSORIES) HGK KARL STORZ ENDOSCOPY-AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R| S