MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-01 for NO NEEDLE ELECTROLYSIS manufactured by American Hair Removal System.
[9376]
Rptr followed all instructions as to hair removal and the hair did not slide out. She paid 3495. 00 for the unit, has returned the unit to the co, but has not received any refund from them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000051 |
| MDR Report Key | 10665 |
| Date Received | 1993-10-01 |
| Date Added to Maude | 1993-12-29 |
| 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 | NO NEEDLE ELECTROLYSIS |
| Product Code | KCW |
| Date Received | 1993-10-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10665 |
| Manufacturer | AMERICAN HAIR REMOVAL SYSTEM |
| Manufacturer Address | MACON GA 31204 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1993-10-01 |