MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-20 for COMMANDER POWERTRACK II * manufactured by Jtech Medical.
[1538342]
After performing hand held dynamometry with the patient, a rash was noted in the location of pressure in all areas where the dynamometer was placed on the patient's skin. The rash remained approximately one hour. The md was notified. The patient was supposed to be re-tested two weeks after the procedure, but this has been canceled. Contacted the manufacturer of the dynamometer and was told that there is no latex in the head of the device. ====================== health professional's impression======================unknown====================== manufacturer response for muscle dynamometer, commander ii power track. ======================said no latex in head that touches patient's skin
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1702162 |
| MDR Report Key | 1702162 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-05-20 |
| Date of Event | 2010-05-18 |
| Report Date | 2010-05-20 |
| Date Reported to FDA | 2010-05-20 |
| Date Added to Maude | 2010-05-28 |
| 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 | RISK MANAGER |
| 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 | COMMANDER POWERTRACK II |
| Generic Name | MUSCLE DYNAMOMETER |
| Product Code | HRW |
| Date Received | 2010-05-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JTECH MEDICAL |
| Manufacturer Address | 470 LAWNDALE DR., STE. G SALT LAKE CITY UT 84115 US 84115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-20 |