IPT WITH LEVULAN *

MAUDE Adverse Event Report

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.

Event Text Entries

[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

MAUDE Entry Details

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

Device Details

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	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly; 2. Required No Informationntervention	2005-08-11