MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-11 for IPT WITH LEVULAN * manufactured by Na.
[532206]
I got some acne on my face so i went to a doctor to have the problem fixed. I went for a consultation and my doctor recommended ipt with levulan. I agreed to my doctor's advice and after two treatments, the acne on my face had gotten worse. He had warned me that it will get worse before it gets better--but at the beginning of the treatment--i didn't have cyst pimples--i only had clogged pores from the black heads. Now, i have cyst pimples all over my face. I paid to get more pimples. In addition, the scar from the ever growing pimples since the start of my treatment has quadrupled. My face has never been so painful as this before.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1036322 |
MDR Report Key | 751966 |
Date Received | 2005-08-11 |
Date of Report | 2005-08-11 |
Date of Event | 2005-08-11 |
Date Added to Maude | 2006-08-21 |
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 | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | IPT WITH LEVULAN |
Generic Name | LEVULAN STICK AND U BLUE LIGHT |
Product Code | OLP |
Date Received | 2005-08-11 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 739757 |
Manufacturer | NA |
Manufacturer Address | * * * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2005-08-11 |