PHILIPS SHADE 3 ACE IR GB-G3-70F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for PHILIPS SHADE 3 ACE IR GB-G3-70F manufactured by Phillips Safety Products.

Event Text Entries

[40059965] I have a pair of phillips ace ir shade 3 safety glasses for borosilicate glass blowing. They are supposed to block out harmful orange sodium flare and they fail to do so. I noticed extreme eye strain after working for anymore than 4 hours at a time and decided to look into the issue. I posted video on a well known glass blowing forum showing my glasses in action and i was shocked at the response. People are telling me my glasses are failing to block out the harmful sodium flare that is so dangerous for your eyes. It immediately reminded me of the eye strain i've been experiencing. Since then, many people have come forward with faulty glasses from philips. There is also evidence that philips has used an experimental lens after running out of stock of the original lens used. (b)(6 ) this is my home address. No first aid or medical attention received. Safety glasses for blocking harmful infrared, uv and sodium flares while working borosilicate glass at high temps. (b)(6). The product was damaged before the incident: no. The product was modified before the incident: no. Have you contacted the manufacturer? Yes. Explanation: i've heard nothing back after calling and emailing. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060794
• MDR Report Key: 5489906
• Date Received: 2016-03-07
• Date of Report: 2016-02-29
• Date of Event: 2016-02-27
• Date Added to Maude: 2016-03-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PHILIPS SHADE 3 ACE IR
• Generic Name: PHILIPS SHADE 3 ACE IR
• Product Code: HQY
• Date Received: 2016-03-07
• Model Number: GB-G3-70F
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILLIPS SAFETY PRODUCTS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-03-07