MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-30 for BIONICARE KNEE DEVICE B1000 manufactured by Bionicare.
[20203385]
The patient used the device on her left leg and suffered burns to her leg. The patient contacted her dr who advised her to immediately discontinue use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004222 |
| MDR Report Key | 935943 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-10-17 |
| Date Added to Maude | 2007-11-13 |
| 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 | 2007-10-30 |
| Model Number | B1000 |
| ID Number | KLM000017181 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911520 |
| Manufacturer | BIONICARE |
| Manufacturer Address | SPARKS MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-30 |