BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX ® LANCET DEVICE

    MDR report key: 14249916 · Received April 29, 2022

    Report

    Report Number
    3011393376-2022-01246
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 19, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BALDA MEDICAL GMBH & CO. KG
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109504 SOFTCLIX ® LANCET DEVICE LANCET DEVICE FMK BBC155

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male