BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MURANAKA SURGICAL MARKING PEN W;/RULER AND 6-UP LABELS, STERILE

    MDR report key: 12075959 · Received June 28, 2021

    Report

    Report Number
    1836161-2021-00025
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    August 31, 2020
    Report Date
    May 31, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. ITEM WAS NOT IN USE. NO INJURY OR DEATH WAS REPORTED. CUSTOMER REPORTED MULTIPLE LOTS FOR THE SAME ISSUE. THE LOT NUMBERS AND THEIR RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4), LOT 207433. (B)(4), LOT 216767. (B)(4), LOT 218179. (B)(4), LOT 211139. (B)(4), LOT 221251. (B)(4), LOT 224335.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978259 MURANAKA SURGICAL MARKING PEN W;/RULER AND 6-UP LABELS, STERILE MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA MMI02730PBX SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1