BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD MICROSET WITH FILTER

    MDR report key: 5553844 · Received April 4, 2016

    Report

    Report Number
    MW5061527
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 4, 2016
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BODYGUARD TUBING REF #(B)(4), LOT 12424327, EXP. 12/2020, WAS FOUND TO HAVE A PIECE OF BLACK FOREIGN MATTER WITHIN THE PACKAGING. THE PRODUCT IS NOT COMPOUNDED. THE PRODUCT IS NOT OVER-THE-COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202051 BODYGUARD MICROSET WITH FILTER BODYGUARD MICROSET WITH FILTER FPA CAESAREA MEDICAL ELECTRONICS LTD. 12424327

    Patients

    Seq Age Sex Outcome Treatment
    1