MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-11 for DIATHERMY ULTRASONIC 950 * manufactured by Dynatronics Corporation.
[776585]
Pt came for physical therapy for his left shoulder. Upon arrival, he informed his therapist that he had blisters on his left shoulder when he got home after his last therapy session two days earlier. Upon inspection by his therapist, indeed there were two rather circular burn-appearing lesions; one on the anterior and one on the posterior aspect of left shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 975904 |
| MDR Report Key | 975904 |
| Date Received | 2007-12-11 |
| Date of Report | 2007-12-11 |
| Date of Event | 2007-11-16 |
| Report Date | 2007-12-11 |
| Date Reported to FDA | 2007-12-11 |
| Date Added to Maude | 2008-01-09 |
| 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 |
| 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 | DIATHERMY ULTRASONIC 950 |
| Generic Name | STIMULATOR, MUSCLE, ULTRASOUND |
| Product Code | IMI |
| Date Received | 2007-12-11 |
| Returned To Mfg | 2007-12-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943920 |
| Manufacturer | DYNATRONICS CORPORATION |
| Manufacturer Address | 7030 PARK CENTRE DRIVE SALT LAKE CITY UT 84121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-11 |