MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-05 for AMREX MS-322 * manufactured by Med Electronics Dynatronics.
[18842318]
During a routine visit on (b)(6), 2010 for treatment of lower back pain and to relax fatigued muscles, electrical stimulation and ultrasound treatment was applied by (b)(6) of quail valley chiropractic resulting in a serious injury with first and second degree burns over a very large area of my backside. This treatment resulted in burns, blistering of the skin, and severe pain that lasted more then a week requiring immediate medical intervention and antibiotic treatment for burns/blisters and long term dermatological treatment for scarring and pigmentation skin discoloration. At the time of treatment, i felt a pulsating, tingling sensation. Equipment used in treatment include amr ex model ms322/dynatronics, sigma spray electrode solution by parker laboratories, inc. And dynatronics model dynatron 125 by ultrasound gel script hessco.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022134 |
| MDR Report Key | 2240787 |
| Date Received | 2011-09-05 |
| Date of Report | 2011-09-05 |
| Date of Event | 2010-12-20 |
| Date Added to Maude | 2011-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMREX MS-322 |
| Generic Name | MUSCLE STIMULATOR |
| Product Code | IPF |
| Date Received | 2011-09-05 |
| Model Number | MS-322 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED ELECTRONICS DYNATRONICS |
| Manufacturer Address | * * * |
| Brand Name | DYNATRONIS DYNATRON |
| Generic Name | MUSCLE STIMULATOR |
| Product Code | IMI |
| Date Received | 2011-09-05 |
| Model Number | DYNATRON 125 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | DYNATRONICS |
| Brand Name | SIGMA |
| Generic Name | ELECTRODE SOLUTION |
| Product Code | GYB |
| Date Received | 2011-09-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | PARKER LABORATORIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-09-05 |