MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-01 for TIME MACHINE/ELECTRICAL STIMULATOR manufactured by Connie Stevens Forever Spring Beauty System.
[18141696]
Svc is promoted via television. The complainant alleges that after using the system 7 or 8 times, she began having hair growth on her face, whereever the device was applied. Device is an electrical stimulator used in conjunction with a collagen quencher. Instructions tell you where to place the device on your face for a minute at a time causing you to feel a pulsing electrical stimulation. There are approx 14 points on the face. The complainant saw her dr who at first though it was an allergic reaction. Tests showed no allergic reaction. A check for hormonal imbalance was negative. Complainant said after using the machine she also had tremendous pressure on her forehead and she felt a burning of the mouth and body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000134 |
| MDR Report Key | 11366 |
| Date Received | 1994-02-01 |
| Date of Report | 1993-07-11 |
| Date Added to Maude | 1994-02-09 |
| 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 | TIME MACHINE/ELECTRICAL STIMULATOR |
| Product Code | IRO |
| Date Received | 1994-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11366 |
| Manufacturer | CONNIE STEVENS FOREVER SPRING BEAUTY SYSTEM |
| Manufacturer Address | LOS ANGELES CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-01 |