MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-24 for PULSE LIGHT * manufactured by Unk.
[333162]
The consumer reported the following: they had permanent laser hair removal done on their back and shoulders four times. They were told that it usually takes four to five treatments to take care of the situation. After the second treatment, they became skeptical of the treatment because it did not hurt; there was no pain at all compared to the first treatment which hurt a lot and they could smell burnt hair. After four treatments, they did not see any result at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003504 |
| MDR Report Key | 458116 |
| Date Received | 2003-03-24 |
| Date of Report | 2003-03-24 |
| Date Added to Maude | 2003-05-08 |
| 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 |
| 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 | PULSE LIGHT |
| Generic Name | HAIR REMOVAL SYSTEM |
| Product Code | KCW |
| Date Received | 2003-03-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 447097 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-03-24 |