MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-14 for BIONICARE KNEE DEVICE B1000 manufactured by Bionicare Medical Technologies, Inc.
[680880]
After using the device for several months, the pt developed a large rash on his right thigh. The pt's dr prescribed prednisone for the rash, and the pt discontinued use of the device. The pt called in to medical when the rash healed and was sent aloe vera gel to use with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003451 |
| MDR Report Key | 899871 |
| Date Received | 2007-08-14 |
| Date of Report | 2007-08-10 |
| Date of Event | 2007-04-10 |
| Date Added to Maude | 2007-08-28 |
| 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 |
| 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 | BIONICARE KNEE DEVICE |
| Generic Name | BIONICARE KNEE DEVICE |
| Product Code | NYN |
| Date Received | 2007-08-14 |
| Model Number | B1000 |
| ID Number | KRM000013750 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 877751 |
| Manufacturer | BIONICARE MEDICAL TECHNOLOGIES, INC |
| Manufacturer Address | SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-14 |