BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR. DON'S ARM CANOE; VELCRO; (20801-V); STERILE

    MDR report key: 13515066 · Received February 11, 2022

    Report

    Report Number
    1836161-2022-00004
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 14, 2022
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT A SEAL ISSUE WAS DISCOVERED WITH THE PRODUCT. THE ITEM WAS NOT IN USE. NO INJURY OR DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBERS AND THEIR RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4) LOT 031020, (B)(4) LOT 051320, (B)(4) LOT 020321, (B)(4) LOT 011321.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2903990 DR. DON'S ARM CANOE; VELCRO; (20801-V); STERILE PATIENT POSITIONING - SHOULDER CCX ASPEN SURGICAL PRODUCTS, CALEDONIA 711501 SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown