BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS

    MDR report key: 12076836 · Received June 28, 2021

    Report

    Report Number
    1836161-2021-00028
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 1, 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 MARKING PEN WAS DISCOVERED WITH A SEALING ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/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 243723. (B)(4), LOT 241548.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978315 RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA 2650 SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1