MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-15 for MICROWAVE MACHINE NI manufactured by *.
[237642]
Dr removed hair from rptr's back using a microwave machine at his office. As a result, rptr suffered severe burns across the areas of their back that he treated. Rptr would like to know if this machine is fda approved for this type of treatment and would like to make a formal complaint regarding its improper use on them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023420 |
| MDR Report Key | 360900 |
| Date Received | 2001-11-15 |
| Date of Report | 2001-11-15 |
| Date of Event | 2001-05-01 |
| Date Added to Maude | 2001-11-26 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROWAVE MACHINE |
| Generic Name | MICROWAVE MACHINE |
| Product Code | MWY |
| Date Received | 2001-11-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 350058 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-11-15 |