BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 8731164 · Received June 25, 2019

    Report

    Report Number
    1526439-2019-51796
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NDN
    UDI-DI
    10705034209630
    PMA / PMN Number
    K060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). SUBMITTER OCCUPATION IS UNKNOWN. (B)(4), UNKNOWN. A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PHYSICIAN REPORTED THAT AFTER MERGING ALL THE INGREDIENTS, THEY RECEIVED ONLY SEVEN (7) MLN OF CEMENT. IN ADDITION, THE CONSISTENCY OF THE PRODUCT DISQUALIFIED IT TO USE. THE PROCEDURE COMPLETED BY USING ANOTHER ONE PRODUCT OF THE SAME TYPE. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524341 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN MEDOS INTERNATIONAL SàRL CH 283913000 10705034209630

    Patients

    Seq Age Sex Outcome Treatment
    1