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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the employee was handling the rapicide with nitrile gloves and spilled the product on their gloves while changing bottles into the aer's interior cabinet.The product subsequently reached the employee's hands, causing the reported event.The following language related to safe handling of the rapicide pa high-level disinfectant can be found on the sds, "causes skin irritation.Symptoms may include redness, edema, drying, defatting and cracking of the skin.Wash hands thoroughly after handling.Wear protective gloves/eye protection/face protection.If on skin: wash with plenty of water.Take off contaminated clothing and wash it before reuse.If skin irritation occurs: get medical advice/attention." the rapicide pa part a sds provides the following warning language and guidance, related to skin exposure and ppe usage: "causes severe skin burns and eye damage.Wash hands thoroughly after handling.Wear protective gloves/protective clothing/eye protection/face protection.If on skin (or hair): rinse skin with water/shower." no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee received "minor burns" on their hands from rapicide pa high level disinfectant.The employee washed their hands until symptoms were resolved.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Common Device Name: 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 Key: 18769005
• Report Number: 2150060-2024-00011
• Device Sequence Number: 18053843
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown