MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for DYNATRON 650 D650-CE006059 manufactured by Dynatronics Corp.
[78815951]
Patient Sequence No: 1, Text Type: N, H10
[78815952]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6680529 |
| MDR Report Key | 6680529 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-15 |
| Date of Event | 2016-11-28 |
| Report Date | 2017-06-15 |
| Date Reported to FDA | 2017-06-15 |
| Date Reported to Mfgr | 2017-06-15 |
| Date Added to Maude | 2017-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNATRON 650 |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2017-06-30 |
| Model Number | D650-CE006059 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNATRONICS CORP |
| Manufacturer Address | 7030 PARK CENTRE DR. SALT LAKE CITY UT 84121 US 84121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |