MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-01 for RICHMAR AUTOSOUND 9.6 manufactured by .
[20306652]
Small circular reddened area the size of a pencil eraser head was noted on pt's right low back prior to the beginning of the 10th physical therapy treatment session. Skin integrity was intact without open sore/wound. Pt did not voice complaint about skin integrity or notice reddened area on right low back. Pt was advised to right skin irritation on low back and advised to monitor skin integrity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016151 |
| MDR Report Key | 1711466 |
| Date Received | 2010-06-01 |
| Date of Report | 2010-06-01 |
| Date of Event | 2010-04-14 |
| Date Added to Maude | 2010-06-08 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHMAR |
| Generic Name | STIMULATOR |
| Product Code | IPF |
| Date Received | 2010-06-01 |
| Model Number | AUTOSOUND 9.6 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | GENTLE STIM CONTROL |
| Generic Name | INTERFERENTIAL >30 MA |
| Product Code | LIH |
| Date Received | 2010-06-01 |
| Lot Number | 60221108043 |
| ID Number | AV= AXE62096 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL ALLIANCE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-01 |