MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-04 for PALOMAR MEDILUX * manufactured by Palomar Medical Technologies.
[313927]
Starting in 2004 to present, facility has had -ipl- intensed pulsed light treatments for hair removal in a small area on the face. They now have a large area covering the face with a high volume of unwanted hair growth that was not there prior to treatments. Called the company & they said this has been known to happen. The heat from the ipl triggers something in the lymphatic system & can create more hair growth, but they did not have to disclose this to patients because it does not always happen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033394 |
| MDR Report Key | 557966 |
| Date Received | 2004-10-05 |
| Date of Report | 2004-10-04 |
| Date of Event | 2004-01-10 |
| Date Added to Maude | 2004-12-08 |
| 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 | 3 |
| 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 | PALOMAR MEDILUX |
| Generic Name | INTENSED PULSED LIGHT |
| Product Code | FSQ |
| Date Received | 2004-10-04 |
| Model Number | MEDILUX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 547633 |
| Manufacturer | PALOMAR MEDICAL TECHNOLOGIES |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-10-05 |