Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYNATRONICS CORP DYNATRON 650; INTERFERENTIAL CURRENT THERAPY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DYNATRONICS CORP DYNATRON 650; INTERFERENTIAL CURRENT THERAPY Back to Search Results
Model Number D650-CE006059
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Erythema (1840); Discomfort (2330)
Event Date 11/28/2016
Event Type  malfunction  
Event Description
Patient received mhp (moist heat pack) and ifc (interferential current) approximately seven months ago.Electrodes were placed on her upper lumbar paraspinals approximately 2cm laterally from existing fully healed surgical incision.When e-stim was first turned on, patient reported mild discomfort from one of the electrode areas, but was not specific.E-stim was turned down immediately and patient then reported no undue discomfort or unusual sensation.Skin was checked post treatment-noted usual mild erythema from hot pack at low back and right hip area.No redness was noted under any of the electrodes sites.When patient arrived for the next pt session, she reported she had a "spot" on her back that she thought might of been from one of the electrodes.Area assessed and noted a small healing area of redness measuring 3cm long x 0.5cm wide with a very small healing blistered area that measured 0.3cm in diameter.All areas dry and clean with no drainage noted.Patient had no c/o pain or undue reaction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DYNATRON 650
Type of Device
INTERFERENTIAL CURRENT THERAPY
Manufacturer (Section D)
DYNATRONICS CORP
7030 park centre dr.
salt lake city UT 84121
MDR Report Key6680529
MDR Text Key78815952
Report Number6680529
Device Sequence Number1
Product Code LIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberD650-CE006059
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2017
Event Location Other
Date Report to Manufacturer06/15/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
-
-