UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-22 for UNK * manufactured by *.

Event Text Entries

[1034995] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009651
MDR Report Key1293886
Date Received2009-01-22
Date of Report2009-01-22
Date of Event2008-12-09
Date Added to Maude2009-02-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameMVT - MICROVIBRATION TECHNOLOGY
Product CodeIRO
Date Received2009-01-22
Returned To Mfg2009-01-07
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Sequence No1
Device Event Key0
Manufacturer*
Manufacturer Address2110 PINTO LANE LAS VEGAS NV 89106 US 89106


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-01-22

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