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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: METREX RESEARCH METRICIDE OPA PLUS; STERILANT
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METREX RESEARCH METRICIDE OPA PLUS; STERILANT Back to Search Results
Catalog Number 10-6000
Device Problem Insufficient Information (3190)
Patient Problem Asthma (1726)
Event Type  Injury  
Manufacturer Narrative
During her employment the complainant handled different disinfectants, sanitizers, and other chemical products.No patient information was provided in regards to age, weight, ethnicity and race.Date of event was not provided.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
An alleged complaint was reported that employee developed respiratory disease specifically reactive airway disease during her employment at a hospital where the product was used.
 
Manufacturer Narrative
Awareness date was corrected.
 
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Brand Name
METRICIDE OPA PLUS
Type of Device
STERILANT
Manufacturer (Section D)
METREX RESEARCH
28210 wick road
romulus, MI 48174
MDR Report Key7969561
MDR Text Key123843139
Report Number1722021-2018-00005
Device Sequence Number1
Product Code MED
Combination Product (y/n)N
PMA/PMN Number
K140703
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number10-6000
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
METRICIDE OPA PLUS SOLUTION TEST STRIPS; P&A SYSTEM 83 PLUS ULTRASONIC WASHER; RAPIDCIDE PA 30C HIGH LEVEL DISINFECTANT; RAPIDCIDE PA 30C HIGH LEVEL DISINFECTANT; RAPIDCIDE PA TEST STRIPS; SYSTEM 83 PLUS ULTRASONIC WASHER; METRICIDE OPA PLUS SOLUTION TEST STRIPS; P&A SYSTEM 83 PLUS ULTRASONIC WASHER; RAPIDCIDE PA 30C HIGH LEVEL DISINFECTANT; RAPIDCIDE PA 30C HIGH LEVEL DISINFECTANT; RAPIDCIDE PA TEST STRIPS; SYSTEM 83 PLUS ULTRASONIC WASHER
Patient Outcome(s) Other;
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