BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICAIR VECTOR

    MDR report key: 2030569 · Received March 21, 2011

    Report

    Report Number
    MW5019911
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 21, 2011
    Manufacturer
    THE COMFORT COMPANY
    Product Code
    IMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADULT MALE PT WITH SPASTIC QUADRAPLEGIA, WHO USES A MOTORIZED WHEELCHAIR WITH A VICAIR "VECTOR" SEAT CUSHION MFG BY "THE COMFORT COMPANY" OF (B)(4), HAS DEVELOPED A FISSURE IN HIS ANAL AREA NEAR THE COCCYX. WE BELIEVE THIS IS A DIRECT RESULT OF THE MFR OF THE VICAIR "VECTOR" SEAT CUSHION REDUCING THE NUMBER OF INDIVIDUAL "COMFORT CELLS" THAT ARE PLACED INSIDE THE CUSHION. WHEN WE COMPLAINED TO THE SUPPLIER, WE WERE TOLD THAT ANOTHER PT HAS HAD PROBLEMS WITH THE CUSHION LACKING THE PROPER NUMBER OF CELLS, AND THAT WHEN OUR SUPPLIER CALLED THE DISTRIBUTOR, THE DISTRIBUTOR NOTED THAT THE MFR HAD REDUCED THE NUMBER OF CELLS IN THE CUSHION, BUT GAVE NO EXPLANATION AS TO WHY THIS WAS DONE. THIS CUSHION AND A PREVIOUS ONE WHICH CONTAINS CONSIDERABLY MORE CELLS, WERE BOTH RECOMMENDED FOR THIS PT BY A THERAPIST AFTER A WHEELCHAIR SEATING EVAL. WE BELIEVE THIS PT MAY HAVE TO BE HOSPITALIZED FOR THIS CONDITION IN THE NEAR FUTURE UNLESS IT RESOLVES ITSELF. DATES OF USE: (B)(6) 2011 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICAIR VECTOR WHEELCHAIR SEATING CUSHION FOR PRESSURE IMP THE COMFORT COMPANY VT-S-1818

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability