MAUDE Adverse Event Report: PRESTIGE BRANDS / MEDTECH PRODUCTS INC. CLEAR EYES

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/03/2017

Event Type  No Answer Provided  

Event Description

Used contact solution containing hydrogen peroxide directly in my eye."is the product over-the-counter: yes; did the product stop after the person reduced the dose or stopped taking or using the product: no.".

• Brand Name: CLEAR EYES
• Type of Device: CLEAR EYES
• Manufacturer (Section D): PRESTIGE BRANDS / MEDTECH PRODUCTS INC.
• MDR Report Key: 6696831
• MDR Text Key: 79650546
• Report Number: MW5070869
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 79