MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-09 for BURDICK D900 SHORT WAVE DIATHERMY D-900 * manufactured by Spacelabs/burdick, Inc..
[19776223]
Pt receiving diathermy for cervical disc disease to left shoulder. Sustained two circular burns (approx 4 cm) to left posterior shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 258546 |
| MDR Report Key | 258546 |
| Date Received | 1999-12-09 |
| Date of Report | 1999-07-15 |
| Date of Event | 1999-07-06 |
| Date Facility Aware | 1999-07-06 |
| Report Date | 1999-07-15 |
| Date Reported to Mfgr | 1999-11-09 |
| Date Added to Maude | 2000-01-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURDICK D900 SHORT WAVE DIATHERMY |
| Generic Name | MEDICAL DIATHERMY |
| Product Code | IMJ |
| Date Received | 1999-12-09 |
| Model Number | D-900 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 20 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 250379 |
| Manufacturer | SPACELABS/BURDICK, INC. |
| Manufacturer Address | 500 BURDICK PARKWAY DEERFIELD WI 53531 US |
| Baseline Brand Name | BURDICK |
| Baseline Generic Name | D-900 SHORT WAVE DIATHERMY |
| Baseline Model No | D-900 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-12-09 |