MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-14 for STIMULATOR, NEUROMUSCULAR manufactured by Dynatronics.
[25790]
Pt was set up on device to right foot in an interferential pattern because of excessive distal edema. Unit was placed in edema reducing mode and intensity was increased to 50. No sign of electrical current was noted. The intensity was lowered to 0 and all plug-ins were and leads were pushed in firmly. The intensity was increased with signs of current at 33. Treatment time was set for 20 mins. Thirteen mins into treatment, when asked, pt reported pain at treatment area. Intensity reduced to 30 and pain was relieved. No visible sign of skin damage present at that time. At the end of the treatment the electrodes were noted as hot and severe burns were observed. The pt has subsequently been surgically treated for these burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34786 |
| MDR Report Key | 34786 |
| Date Received | 1996-05-14 |
| Date of Report | 1996-05-13 |
| Date of Event | 1996-03-06 |
| Date Added to Maude | 1996-08-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMULATOR, NEUROMUSCULAR |
| Generic Name | STIMULATOR, NEUROMUSCULAR |
| Product Code | LIH |
| Date Received | 1996-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 36166 |
| Manufacturer | DYNATRONICS |
| Manufacturer Address | 7030 PARK CENTRE DR SALT LAKE CITY UT 841216618 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-05-14 |