MULTILIGHT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-18 for MULTILIGHT * manufactured by Lumenis.

Event Text Entries

[17171888] Pt had a fotofacial treatment at a local dermatologist who used the multilight, intense pulsed light machine. They have been experiencing very painful and constant side effects ever since. During the treatment, the multilight was inadvertently directed into pt's un-protected eye. Pt felt immediate burning and pain in the eye, and now, over a month later, the pain still remains. Pt has been to an ophthalmologist, a retinal specialist, and neurologist, and all three, while unfamiliar with the multilight, could find no physical damage. Pt is simply looking for answers and wish to stop the pain. Pt asks what could be happening to cause the persistent pain. They request resources for info concerning studies and testing on this machine and any suggestions for a course of action to resolve the ongoing, 24 hr-a-day pain. Pt asks if this has been approved by the fda and if there is a regulatory body for this in their state.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025356
• MDR Report Key: 401021
• Date Received: 2002-06-18
• Date of Report: 2002-06-18
• Date of Event: 2002-05-17
• Date Added to Maude: 2002-06-25
• 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

Device Details

• Brand Name: MULTILIGHT
• Generic Name: INTENSE PULSED LIGHT
• Product Code: FTC
• Date Received: 2002-06-18
• 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: 390058
• Manufacturer: LUMENIS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-06-18