MAUDE Adverse Event Report: METREX RESEARCH CAVICIDE SURFACE DISINFECTANT

Catalog Number 13-1024

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Blurred Vision (2137)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

The patient saw an optometrist who prescribed antibiotics and dexamethosone eye drops. Pain has decreased and vision is no longer blurry. She is expected to make a full recovery. No patient information was provided in regards to age, weight, ethnicity and race. No information was provided in regards to lot number; therefore device manufacturing date could not be determined. The product involved in the alleged incident was not returned and no lot number was provided; therefore no further evaluation could be done.

Event Description

A staff member got cavicide in both her eyes while cleaning, pain and blurry vision ensued. No personal protective equipment was worn.

• Brand Name: CAVICIDE
• 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 w collins avenue; orange, CA 92867 ; 7145167752
• MDR Report Key: 7820484
• MDR Text Key: 118405951
• Report Number: 1722021-2018-00004
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 13-1024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/27/2018 Patient Sequence Number: 1