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 .
[1397799]
Approx 1 cm reddened circular area of right low back was noted by the therapist prior to the beginning of the 11th p. T. -physical therapy- session. Slight disruption in skin integrity was noted at that specific site without drainage or odor. Pt did not voice any complaints about skin integrity or notice any skin problems to low back. Pt was advised or right low back decreased skin integrity and advised to cleanse area, apply bacitracin/neosporin and cover with a band aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016152 |
| MDR Report Key | 1711467 |
| Date Received | 2010-06-01 |
| Date of Report | 2010-06-01 |
| Date of Event | 2010-04-09 |
| 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 | IMI |
| 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 > 30MA |
| Product Code | IMI |
| Date Received | 2010-06-01 |
| Lot Number | 60590309 |
| ID Number | PN-AXE 62093 |
| 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 |