HYDROGEN PEROXIDE CLEANING SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for HYDROGEN PEROXIDE CLEANING SOLUTION manufactured by Unk.

Event Text Entries

[178263700] I am going on vacation to the beach for christmas and have to buy my usual saline solution. I bring both bottles up to the pharmacist to ask if they're the same or just a difference in price? She assures me they are the exact same thing. She reads the ingredients and says yeah they work the same and even opens the box and sees a weird contact lenses case and says she's never seen that before but still firmly says it's the same thing. I go home and don't really understand so i let them soak and do the mistake of putting them in my eye. The pain burned so much like acid in my eye that my eye involuntarily closed shut and i had to pry my eye open to get it out. It's been close to 48 hours and i still feel like something is in my eye and my eye is still completely red. When and how was error discovered: at home. The pharmacist told me firmly saying it is the same, and as a result i burned my eye. Without insurance i am stuck dealing with a burning red eye and close to 48 hours no major improvements. (b)(6), access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092818
• MDR Report Key: 9677095
• Date Received: 2020-02-05
• Date of Report: 2020-02-05
• Date of Event: 2019-01-01
• Date Added to Maude: 2020-02-06
• 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: 3

Device Details

• Brand Name: HYDROGEN PEROXIDE CLEANING SOLUTION
• Generic Name: ACCESSORIES, SOFT LENS PRODUCTS
• Product Code: LPN
• Date Received: 2020-02-05
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-05