[1267241]
My spouse visited a chiropractor in '08 for on-going lower back pain that was intermittent. On the 2nd visit, in the same month, the chiropractor performed a spinal decompression using this device. She was only under the use of the device for less than 5 minutes and she complained of severe pain. We are not sure if it was improperly set up, but the device definitely caused her severe pain, and she has been in chronic back pian since this procedure was performed. She is now in 24x7 pain, requiring prescription pain medicines daily and she may have suffered irreparable damage for the rest of her life. Prior to his procedure, she only suffered occasional pain that otc medication could relieve. I noticed another adverse event report was submitted, that closely matches what my spouse encountered. Her pain now is 24x7 and is much more elevated than previous to this procedure. I would appreciate some feedback on these devices by the fda. Are they periodically checked to ensure they are operating according to specifications? Are the staff that set up the devices certified and trained by qualified personnel. Does the fda regulate who can operate the device.
Patient Sequence No: 1, Text Type: D, B5