BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAREX & ASPIREX DRIVE SYSTEM

    MDR report key: 15369462 · Received September 7, 2022

    Report

    Report Number
    3008439199-2022-00123
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 27, 2022
    Manufacturer
    UNKNOWN
    Product Code
    MCW
    UDI-DI
    07640142810889
    PMA / PMN Number
    K211738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, THE CONVENIENCE STICKER IS PART OF THE INTERNAL PROCESS AND NOT RELATED TO MANUFACTURING/SERVICE LABELING ISSUE AND HENCE THIS RECORD WILL NOT BE CONSIDER AS A COMPLAINT. HOWEVER, SINCE AN INITIAL MDR WAS SUBMITTED, THE FILE WILL REMAIN ASSESSED AS A MALFUNCTION. THE MEDICAL DEVICE MANUFACTURER (D3) AND MANUFACTURING LOCATION (G1) FOR THE STRAUB PRODUCT WAS SELECTED AS UNKNOWN DUE TO SYSTEM LIMITATIONS. THE CORRECT MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION ARE STRAUB MEDICAL US. D4 (EXPIRY DATE: 12/2040), G3. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION FOR THE STRAUB PRODUCT WAS SELECTED AS UNKNOWN DUE TO SYSTEM LIMITATIONS. THE CORRECT MEDICAL DEVICE MANUFACTURER AND MANUFACTURING LOCATION ARE STRAUB MEDICAL US. AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 12/2040).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486575 ROTAREX & ASPIREX DRIVE SYSTEM THROMBECTOMY & ATHERECTOMY MCW UNKNOWN VERSION 1.0 07640142810889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown