FDA Adverse Event Other Summary report: N

UNK

MDR report key: 1293886 · Received January 22, 2009

Report

Report Number
MW5009651
Event Type
Other
Date Received
January 22, 2009
Date of Event
December 9, 2008
Report Date
January 22, 2009
Manufacturer
*
Product Code
IRO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

AFTER READING ABOUT A DEVICE CALLED MICROVIBRATION TECHNOLOGY IN HEALTH NEWSLETTER, I CALLED THE PHONE NUMBER PROVIDED AND LEFT A MESSAGE TO INQUIRE ABOUT THE PRODUCT. A DR WROTE OF FANTASTIC RESULTS IN RELIEVING PAIN WITH THIS DEVICE, EVEN IN PATIENTS WITH DECADES-OLD PAIN AND INJURIES. I HAVE SPORTS INJURIES THAT OCCASIONALLY BOTHER ME SUCH AS TENDONITIS IN MY SHOULDER WHICH HAD RECENTLY BEEN AGGRAVATED BY HEAVY LIFTING AS WELL AS A KNEE INJURY WHICH HAD BEEN SUCCESSFULLY TREATED WITH PHYSICAL THERAPY ABOUT 10 YEARS AGO, BUT WHICH GIVES ME OCCASIONAL TWINGES WHEN I OVERDO IT OR TWIST MY KNEE DURING SPORTS. SOME WEEKS LATER, MY PHONE CALL WAS RETURNED BY THE OFFICE OF THE INVENTOR, ANOTHER DR WHO APPARENTLY MAINTAINS A CLINIC. I WAS ADVISED THAT THE DEVICE SELLS. THIS PRICE SEEMED QUITE STEEP BUT I WAS TOLD OF THE FANTASTIC RESULTS, WHICH WOULD OFFSET MY PHYSICAL THERAPY SESSIONS AND PAY OFF IN THE LONG TERM. AS A READER OF NEWSLETTER, I WAS OFFERED A 30-DAY TRIAL. I WAS LED TO BELIEVE THAT THE DEVICE DID NOT HELP EVERYONE BUT THAT I HAD NOTHING TO LOSE BY TRYING IT. BECAUSE THE DEVICE UTILIZES ACUPRESSURE POINTS - AND I HAVE HAD GREAT SUCCESS WITH ACUPUNCTURE IN RELIEVING PAIN - I DECIDED TO TRY IT. WHEN THE DEVICE ARRIVED, AND FOLLOWING THE INSTRUCTIONS INCLUDED, I USED THE DEVICE AS INSTRUCTED. INSTEAD OF RELIEVING PAIN, IT INCREASED IT TO THE POINT THAT I WAS UNABLE TO SLEEP FOR SEVERAL WEEKS BECAUSE OF THE UNRELENTING DISCOMFORT IN MY SHOULDERS. I CONTACTED (SECOND) DR'S OFFICE AND WAS ADVISED NOT TO USE THE DEVICE FOR A FEW DAYS, THEN TRY AGAIN, WHICH I DID. I THEN ALSO FOLLOWED THE INSTRUCTIONS THAT SUGGESTED USING THE DEVICE ON PARTICULAR POINTS OF DISCOMFORT FOR LONGER PERIODS OF TIME. DR'S OFFICE SUGGESTED THAT THE DEVICE WAS BREAKING UP SCAR TISSUE, WHICH WOULD ACCOUNT FOR THE PAIN BUT I WAS LED TO BELIEVE THAT THIS WAS ALL TO THE GOOD. IN THE LONG TERM, MY PAIN WOULD BE GONE AND MY OLD INJURIES HEALED. AFTER 3 WEEKS AND SEVERAL CALLS TO (SECOND)DR'S OFFICES, I WAS IN TERRIBLE PAIN. I TRIED IT ON MY OLD KNEE INJURY, THINKING IT WOULD HEAL ANY LINGERING SCAR TISSUE THERE AS WELL, BUT IT CREATED UNRELENTING PAIN INSTEAD - ALMOST AS BAD AS IT WAS AFTER I INJURED IT. IN MY FINAL CALL TO (SECOND)DR.'S OFFICE, HE SUGGESTED I GET AN MRI. I HAD AN MRI DONE AFTER MY INITIAL INJURY APPROX 10 YEARS AGO. I WAS UNDER AN ORTHOPEDIC DOCTOR'S CARE THEN, AS WELL AS A PHYSICAL THERAPIST'S, AND THE INJURY HEALED AFTER SOME MONTHS TO THE POINT THAT I WAS PAIN-FREE. THERE WAS NO TEARING OF TISSUE OR LONG-TERM DAMAGE AT THAT TIME. DOSE: 1-2 MINS ON ACUPRESSURE POINTS. FREQUENCY: 1-3 TIMES/DAY. ROUTE: CUTANEOUS. DATES OF USE: 30 DAYS, LATE 2008 - EARLY 2009. DIAGNOSIS: PAIN FROM RECENTLY AGGRAVATED OLD SPORTS INJURIES. EVENT ABATED AFTER USE STOPPED: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNK MVT - MICROVIBRATION TECHNOLOGY IRO * * *

Patients

Seq Age Sex Outcome Treatment
1 54 YR Other