MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-18 for PROTEUS E.P. 2000 manufactured by Proteus Epilators, Inc..
[12688]
Rptr had an electrolysis treatment done. The 5th treatment caused a 1-2 degree burn which left rptr to hide in her house for months. She saw her dr two days after and has also seen a plastic surgeon. The area of hair was changed due to this burn. It was a fine thin hair (brown in color) and now it is just like a man's beard. She is left with hoping the tissue will heal so she can do something about the hair. She has been told the equipment was set too high with too much heat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004085 |
| MDR Report Key | 17867 |
| Date Received | 1994-11-18 |
| Date of Report | 1994-11-07 |
| Date of Event | 1994-04-01 |
| Date Added to Maude | 1994-11-21 |
| 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 | 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 | PROTEUS E.P. 2000 |
| Generic Name | ELECTROLYSIS MACHINE |
| Product Code | KCW |
| Date Received | 1994-11-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17783 |
| Manufacturer | PROTEUS EPILATORS, INC. |
| Manufacturer Address | BELLINGHAM MA 02019 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other; 2. Required No Informationntervention | 1994-11-18 |