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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS INC RAPICIDE PA HIGH-LEVEL DISINFECTANT

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MEDIVATORS INC RAPICIDE PA HIGH-LEVEL DISINFECTANT Back to Search Results
Model Number ML02-0117
Device Problem Insufficient Information (3190)
Patient Problem Skin Discoloration (2074)
Event Date 10/13/2023
Event Type  malfunction  
Manufacturer Narrative
The chemtrec report did not provide a lot number for the rapicide pa high-level disinfectant subject of the reported event.Steris made multiple attempts to contact the user facility to obtain additional information regarding the reported event however, the user facility has not responded.Without the user facility's response, steris is unable to determine a root cause.The safety data sheet for rapicide pa high-level disinfectant states (section 8), "use ventilation adequate to keep exposures (airborne levels of dust, fume, vapor, etc.) below recommended exposure limits.Ensure that eyewash stations and safety showers are close to the workstation location.Wear chemically resistant protective gloves.Wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles) and face protection (face shield).Wear suitable protective clothing.Wear solvent resistant apron and boots for spills." a follow-up report will be submitted should additional information become available.No additional issues have been reported.
 
Event Description
The user facility reported via chemtrec report that an employee "accidently" dropped rapicide pa high-level disinfectant (unknown if it was part a or part b) down the drain.The employee stated she got product on one of her arms which resulted in discoloration of the skin.The employee also stated a strong odor was present when the rapicide pa high-level disinfectant was dropped.The chemtrec report stated the employee was seeking medical attention on site.
 
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Brand Name
RAPICIDE PA HIGH-LEVEL 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 north
minneapolis, MN 55447
4403927453
MDR Report Key18103784
MDR Text Key327757157
Report Number2150060-2023-00047
Device Sequence Number1
Product Code FEB
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 Other Health Care Professional
Type of Report Initial
Report Date 11/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberML02-0117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2023
Initial Date FDA Received11/09/2023
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 Initial
Patient Sequence Number1
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