BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIFORM HEAD REST REPLACEMENT BLADDER

    MDR report key: 1961606 · Received January 10, 2011

    Report

    Report Number
    1221538-2011-00001
    Event Type
    Other
    Date Received
    January 10, 2011
    Report Date
    December 12, 2001
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO SERIAL NUMBER ON THIS VACUUM PRODUCT. ACCORDING TO CUSTOMER SERVICE, THE MOST RECENT PURCHASE BY THIS CUSTOMER WAS IN (B)(6) 2010. THERE WERE NO INJURIES SUSTAINED AND THE PRODUCT IS NOT KNOWN TO HAVE IMPACTED OR DELAYED A CASE. ALLEN HAS CONTACTED THE CUSTOMER TO REQUEST RETURN FOR EVAL.

    Description of Event or Problem · 1

    AN ALLEN SALES REP REPORTED A COMMUNICATION WITH A HOSPITAL DOCTOR AND STAFF EXPRESSING THEIR CONCERN WITH THE THICKNESS OR THE MOST RECENTLY REC'D REPLACEMENT FLEXIFORM HEAD REST BLADDER. THE FLEXIBLE HEAD REST DESIGN INCORPORATES A VACUUM BLADDER FILLED WITH POLYMER MICRO-BEADS THAT CONFORM TO THE PT'S HEAD. THE STAFF VOICED CONCERN THAT INCONSISTENT MICRO-BEAD FILL AND OVERALL THICKNESS COULD IMPACT PTS BY CAUSING "HEAD FLEXATION." ACCORDING TO THE REP, THERE WAS NO PT INVOLVEMENT REPORTED AND NO INJURIES RESULTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFORM HEAD REST REPLACEMENT BLADDER FLEXIFORM REPLACEMENT BLADDER FWZ ALLEN MEDICAL SYSTEMS C-003315-A6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA