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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS, INC. MEDIVATORS DISINFECTANT
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MEDIVATORS, INC. MEDIVATORS DISINFECTANT Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Eye Pain (4467)
Event Date 06/22/2022
Event Type  malfunction  
Manufacturer Narrative
Medivators contacted the complainant for additional information regarding the reported event.The complaint was unable to provide a product name or number for the disinfectant subject of this event.Should we obtain additional information regarding the product subject of this event, a follow-up report would be filed with the results of our investigation.
 
Event Description
A fedex operations manager reported that a medivators disinfectant was damaged during transit allowing the product to leak.Two of the fedex employees were near the product when it spilled.One of the employees reported that they experienced inhalation/irritation.No medical treatment was needed.
 
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Brand Name
MEDIVATORS DISINFECTANT
Type of Device
DISINFECTANT
Manufacturer (Section D)
MEDIVATORS, INC.
14605 28th avenue n
minneapolis MN 55447
Manufacturer (Section G)
MEDIVATORS, INC.
14605 28th avenue n
minneapolis MN 55447
Manufacturer Contact
daniel davy
14605 28th ave n
minneapolis, MN 55447
4403927453
MDR Report Key15084226
MDR Text Key302344035
Report Number2150060-2022-00030
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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