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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: METREX RESEARCH CAVICIDE SURFACE DISINFECTANT

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METREX RESEARCH CAVICIDE SURFACE DISINFECTANT Back to Search Results
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.
 
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Brand NameCAVICIDE
Type of DeviceSURFACE 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 Key7820484
MDR Text Key118405951
Report Number1722021-2018-00004
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951123
Number of Events Reported1
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 Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number13-1024
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 Received07/31/2018
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
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