MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-13 for BIONICARE KNEE DEVICE B1000 manufactured by Bionicare Medical Technologies, Inc..
[15218957]
The patient developed a rash on the knee after using the device for approximately three weeks. The rash continued to spread down the side of the pt's leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004391 |
| MDR Report Key | 947943 |
| Date Received | 2007-11-13 |
| Date of Report | 2007-11-12 |
| Date of Event | 2007-10-04 |
| Date Added to Maude | 2007-11-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIONICARE KNEE DEVICE |
| Generic Name | BIONICARE KNEE DEVICE |
| Product Code | NYN |
| Date Received | 2007-11-13 |
| Model Number | B1000 |
| ID Number | KLS000001517 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921481 |
| Manufacturer | BIONICARE MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-13 |