BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 2623684 · Received June 11, 2012

    Report

    Report Number
    3003508375-2012-00002
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 11, 2012
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS NO EVIDENCE THAT THE REPORTED RASH IS ASSOCIATED WITH THE USE OF THE DEVICE AS THE DEVICE ARMRESTS DO NOT CONTAIN LATEX, TO WHICH THE USER HAS A STATED ALLERGY. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    USER REQUIRED ABOUT THE COMPOSITION OF THE ARMREST MATERIAL ON THE DEVICE. THE USER STATED THAT HE HAS A LATEX ALLERGY AND WAS GETTING RASHES ON HIS ARMS. THE USER STATED THAT THE ARMRESTS WERE NOT DAMAGED, WORN OR CRACKED. THE USER DID NOT ALLEGE THAT THE DEVICE CAUSED THE REPORTED RASH- JUST INQUIRED ABOUT THE MATERIAL. THE CHU NOTED THAT SINCE DATE OF ORIGINAL DELIVERY IN (B)(6) 2007, THE CALL HISTORY FOR THIS DEVICE/ USER DID NOT SHOW ANY OTHER COMPLAINTS REPORTED FOR RASH OR ALLERGIC REACTION. THE COMPANY RECONFIRMED WITH THE ARMREST MFR THAT LATEX IS NOT USED IN THE MFR OF ANY OF ITS PRODUCTS. COMPANY RECORDS ALSO CONFIRM THAT BIOCOMPATIBILITY TESTING PERFORMED DURING DEVICE PRODUCT DESIGN WAS SATISFACTORY AND DID NOT INDICATE ANY BIOCOMPATIBILITY ISSUES WITH THE CHOSEN MATERIALS. THERE HAVE BEEN NO SIMILAR REPORTS FROM ANY OTHER SOURCE. THE COMPANY HAS FOLLOWED UP WITH THE USER REGARDING THE FINDINGS. ALTHOUGH IT IS BELIEVED THAT THE DEVICE IS NOT THE SOURCE OF THE REPORTED EVENT, THE COMPANY HAS ELECTED TO FILE AN ADVERSE EVENT REPORT DUE TO THE REPORTED RASH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. IBOT NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other