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

Model Number	ML02-0117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that rapicide pa high-level disinfectant part a sprayed onto an employee as they were taking the cap off.The employee reported their skin was "burning".The employee rinsed the affected area and sought additional medical treatment.The user facility did not disclose if medical treatment was administered.
Additional Manufacturer Narrative
Medivators has contacted the customer requesting additional information; however, to date the customer has not provided additional information.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." rapicide pa part a is bottled with a vented lid to allow chemical fumigation.The following language is from the rapicide pa label, "store upright in shipping carton.Store in original closed container.Never tamper with vent." it is unknown if the chemistry bottle orientation was changed during transport or storage at the facility.No additional issues have been reported.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13978098
• Report Number: 2150060-2022-00022
• Device Sequence Number: 14978405
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/01/2022

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
• Device Expiration Date: 07/19/2023
• Device Model Number: ML02-0117
• Device Lot Number: 533013
• 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: 03/02/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown