MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-19 for PALOMAR MAX G manufactured by Palomar Medical Technologies, Inc..
[2515278]
I received one ipl treatment on a palomar max g machine. Settings: 32j, 20ms, one pass to face. Adverse reaction resulting in inflammation for months, flushing, burning sensation to face, hyper-sensitivity. Enlarged pores, pin-prick marks, micro-scarring with small lines, indents, and loss of facial volume. Doctor who performed this treatments will not respond to phone calls, emails, or certified letters to help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023937 |
| MDR Report Key | 2428379 |
| Date Received | 2012-01-19 |
| Date of Report | 2012-01-19 |
| Date of Event | 2011-09-22 |
| Date Added to Maude | 2012-01-27 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALOMAR MAX G |
| Generic Name | PALOMAR MAX G |
| Product Code | ILY |
| Date Received | 2012-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALOMAR MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | NETWORK DRIVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-19 |