LASER EYE SAFETY GLASSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for LASER EYE SAFETY GLASSES manufactured by Unk.

Event Text Entries

[107797168] I ordered eye protection from amazon for use with laser lights. When i opened the package the toxic chemicals, from which the glasses and case were made, caused an immediate and severe reaction. My lower body cramped so severely i was unable to walk. I had breathing problems. Right now i have a severe headache. I was exposed for less than 3 mins. It took about 20 mins for the cramps to subside. I will place the products in a plastic bag. The product was manufactured in (b)(4) and i think it should be analyzed for toxicity, but i do not know where to take it. I would like to know where to take this product to be analyzed. I have filed a complaint with both amazon and the distributor. The name of the product is hde eye safety laser protection glasses. The distributor is hde. "is the product over-the-counter: yes, strength: toxic materials, did the problem stop after the person reduced the dose or stopped taking or using the product: yes, did the problem return if the person started taking or using the product again: yes, how was it used: protects eyes material toxic. " date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018. Reason for use: to protect eyes from acne laser for skin.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077077
• MDR Report Key: 7494382
• Date Received: 2018-05-07
• Date of Report: 2018-05-04
• Date of Event: 2018-05-02
• Date Added to Maude: 2018-05-08
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LASER EYE SAFETY GLASSES
• Generic Name: SHIELD, EYE, RADIATION
• Product Code: IWS
• Date Received: 2018-05-07
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-05-07