BEUDAMED
    FDA Adverse Event Other Summary report: N

    NC EXERCISE BAND, LEVEL 3

    MDR report key: 2640028 · Received August 26, 2011

    Report

    Report Number
    2939821-2011-00014
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    August 21, 2009
    Report Date
    August 24, 2011
    Manufacturer
    THAI CENTRI CO, LTD
    Product Code
    ION
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS: NC 91223-50 AND NC91225-50.

    Description of Event or Problem · 1

    RECEIVED CUSTOMER COMPLAINT THAT ONE OF THEIR PT GOT SLAPPED ON THE FACE WHEN A LEVEL 3 EXERCISE BAND SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC EXERCISE BAND, LEVEL 3 EXERCISE BAND ION THAI CENTRI CO, LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other