MAUDE Adverse Event Report: METREX RESEARCH CAVIWIPE1 REGULAR; SURFACE DISINFECTANT

Catalog Number 13-5100

Device Problem Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Caustic/Chemical Burns (2549); Swelling/ Edema (4577)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

A complainant alleged that they pulled the wipe towards the end of the canister, pulled hard, and the wipe flung solution into a person's eye.Burning persisted after flushing eyes for fifteen (15) minutes.Advised to go to er and then was referred to an ophthalmologist.The ophthalmologist gave a diagnosis of corneal swelling, keretosis, and chemical burn in the right eye.The affected person was prescribed tobradex st and an over-the-counter systane lubricating eye drops which were to be taken three (3) times a day for five (5) days.To this date, they are still experiencing eye redness and irritation.

Event Description

A complainant alleged that they pulled the wipe towards the end of the canister, pulled hard, and the wipe flung solution into a person's eye.Burning persisted after flushing eyes for fifteen (15) minutes.Advised to go to er and then was referred to an ophthalmologist.The affected person still has eye redness and irritation to this date.

• Brand Name: CAVIWIPE1 REGULAR
• Type of Device: SURFACE DISINFECTANT
• Manufacturer (Section D): METREX RESEARCH; 28210 wick road; romulus MI 48174
• Manufacturer (Section G): METREX RESEARCH; 28210 wick road; romulus MI 48174
• Manufacturer Contact: paulo calle ; 1717 west collins ave.; orange, CA 92867 ; 7145167752
• MDR Report Key: 11311365
• MDR Text Key: 231339998
• Report Number: 1722021-2021-00001
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 13-5100
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention