BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE

    MDR report key: 11365070 · Received February 23, 2021

    Report

    Report Number
    1836161-2021-00010
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 28, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. NO SAMPLE OR PHOTOGRAPHIC EVIDENCE WAS PROVIDED, THEREFORE THE ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER, IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    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. THIS INCIDENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER C-1181499.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260975 BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE PATIENT POSITIONING - SHOULDER CCX ASPEN SURGICAL PRODUCTS, CALEDONIA 711200 062420

    Patients

    Seq Age Sex Outcome Treatment
    1