MAUDE Adverse Event Report: THERATEARS STERILID ANTIMICROBIAL EYELID CLEANSER AND FACIAL WASH; DRESSING, WOUND, DRUG

Catalog Number	58790000560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial (01-mar-2024): this serious case reported via telephone refers to a 62-year-old female consumer with an allergy to penicillin and sulfa drugs.Medical history and concomitant medications ar1719513-2024-00082e were not reported.On an unreported date a consumer used theratears sterilid antimicrobial eyelid cleanser for ocular rosacea and sclerites once, and experienced a burned cornea, blistering to the inner eye, red eye and eyelids, skin peeling around eyes, and cloudy vision.Consumer was advised to return the product for quality investigation and send in medical records, b1719513-2024-00082ut has yet to do so.This case outcome is not recovered/not resolved.Meddra version 26.1 expectedness: unexpected thermal burns of eye: unexpected retinal disorder: unexpected ocular hyperaemia: expected erythema of eyelid: unexpected eyelid exfoliation: unexpected vision blurred: expected according to the company reference safety information.

• Brand Name: THERATEARS STERILID ANTIMICROBIAL EYELID CLEANSER AND FACIAL WASH
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer Contact: darena wagner ; 4615 murray place; lynchburg 24502
• MDR Report Key: 20772368
• Report Number: 1719513-2024-00082
• Device Sequence Number: 11429317
• Product Code: FRO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/25/2025
• Device Catalogue Number: 58790000560
• Device Lot Number: 5306110352 (INVALID)
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female