BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE

    MDR report key: 11186103 · Received January 18, 2021

    Report

    Report Number
    1836161-2021-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 23, 2020
    Report Date
    December 23, 2020
    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

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT DURING A PROCEDURE, THE DEVICE MALFUNCTIONED. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. PHOTOGRAPHIC EVIDENCE WAS AVAILABLE FOR EVALUATION. A MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. CUSTOMER REPORTED THAT DURING PROCEDURE, THE BERKETTE POSITIONERS FOAM CAME UNDONE FROM THE PLASTIC PIECE THAT CONNECTS TO THE TRIMANO ARTICULATING ARM. PHOTOGRAPHIC EVIDENCED SHOWED THE GLUE/TAPE FAILED TO HOLD FOAM IN CONTACT WITH THE PLASTIC SUPPORT. PLASTIC PIECE IS SHOWN DETACHED AND OUTSIDE OF COBAN WRAP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. NO NON-CONFORMANCE'S WERE NOTED RELATING TO THE REPORTED ISSUE. THE ACTUAL SAMPLE WAS UNAVAILABLE FOR FURTHER EVALUATION; HOWEVER, A REPRESENTED SAMPLE WAS PULLED FOR EVALUATION. DURING THE SAMPLE REVIEW IT WAS FOUND THAT THE PRODUCT DOES NOT EASILY SEPARATE. A FORCED SEPARATION WAS CONDUCTED, DURING THIS ASSESSMENT IT WAS FOUND IT WOULD LEAD TO TEARING, SHEARING AND SHREDDING OF THE FOAM IN VARYING DEGREES. THE FOAM WOULD ALSO LEAVE RESIDUE ONTO THE ADHESIVE IN VARYING DEGREES. FROM THE PHOTO ANGLE PROVIDED IT CANNOT BE CONCLUSIVELY DETERMINED HOW THE PRODUCT SEPARATED. WITHOUT THE SAMPLE FOR ANALYSIS THE COMPLAINT CANNOT BE DETERMINED. BASED ON THIS INFORMATION, NO ADDITIONAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT THE PLASTIC SUPPORT CAME APART FROM THE FOAM ON THE DEVICE. NO PATIENT HARM WAS REPORTED. THIS INCIDENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87188 BERKETTE BEACH CHAIR LIMB POSITIONER; (100801); STERILE PATIENT POSITIONING - SHOULDER CCX ASPEN SURGICAL PRODUCTS, CALEDONIA 711200 062420

    Patients

    Seq Age Sex Outcome Treatment
    1