SOFTWAVE THERAPEUTIC MASSAGER

Description of Event or Problem

A REPORTER CALLED TO SUBMIT A REPORT OF THE ADVERSE EVENTS SHE HAS EXPERIENCED FROM A USE OF A SHOCKWAVE DEVICE. REPORTER STATED HER PHYSICAL THERAPIST STARTED USING THIS DEVICE TO TREAT HER SCIATIC NERVE PAIN AND PUDENDAL NERVE PAIN. REPORTER STATED THE DEVICE IS NOT FDA APPROVED FOR THESE KINDS OF TREATMENTS. THE REPORTER STATED AFTER A FEW TREATMENTS, SHE STARTED FEELING PINS AND NEEDLES ON THE BOTTOM OF HER LEFT FOOT, AND THEN SHE STARTED FEELING PINS AND NEEDLES ON HER LEFT HAND. WHEN THE REPORTER VERBALIZED HER CONCERN TO THE PHYSICAL THERAPIST, SHE WAS TOLD IT IS STRESS. THE PHYSICAL THERAPIST CONTINUED THE THERAPY ON HER RIGHT AND LEFT SCIATICA NERVE AND THE REPORTER CONTINUED TO FEEL PINS AND NEEDLES, ON HER LEFT PALM. THE REPORTER GOT A TOTAL OF 6 OR 7 TREATMENTS. TWO WEEKS AFTER THE END OF HER TREATMENTS, SHE SAID BOTH HER FEET GOT NUMB, STARTED HAVING BURNING PALMS, GETTING STATIC ELECTRICITY ON ALL THE EXTREMITIES AND HER LEFT TOES ARE NUMB TOO. REPORTER STATED SHE IS NOW HAVING PERIPHERAL NEUROPATHY ON HER FEET. SHE SAID SHE HAS BEEN TO A DOCTOR AND A NEUROLOGIST, AND THEY TOLD HER THAT THEY ARE NOT FAMILIAR WITH THE DEVICE. SHE IS SAID SHE IS TAKING GABAPENTIN. SHE IS HAVING PAIN CONTINUOUSLY. SHE SAID BEFORE THE TREATMENT WITH THIS DEVICE, SHE NEVER HAD ANY HEALTH ISSUES.