IPL-AID *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-06 for IPL-AID * manufactured by Glendale.

Event Text Entries

[493363] Pt is a lser pt of ours who first had ipl done in 2006. Her second treatment was done the n ext month, third treatment the next. She came in at 9:30 a. M. This morning for her fourth treatment. She had not had any problems previously with her treatment, except a mild "heat rash" on her face after her second visit, which could be a normal variance of th eipl procedure.. We are in the process of trining our esthetician. She is a licensed esthetician who has gone through cutera laser training. This was the second ipl pt that i wathced her do. She had seen me do four previous ipl pts by myself and i was in the room with her. This time also, i was in the room with her to monitor her correct ipl use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1938466
• MDR Report Key: 728066
• Date Received: 2006-06-06
• Date of Report: 2006-05-30
• Date of Event: 2006-05-12
• Date Added to Maude: 2006-06-23
• 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
• 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

Device Details

• Brand Name: IPL-AID
• Generic Name: IPL-AID DISPOSABLE EYE SHIELDS
• Product Code: HOY
• Date Received: 2006-06-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 716344
• Manufacturer: GLENDALE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2006-06-06