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

Model Number	ML02-0117
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot of the reported product was not provided and the bottle subject of the event was not returned for evaluation.The duration of symptoms was not reported.Protective gloves were not worn while handling the rapicide pa high level disinfectant bottles and this likely contributed to 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 sds was provided to the user facility which indicates the requirement for ppe during handling of rapicide pa high level disinfectant.No additional reports of adverse event or harm were received.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that an employee was handling rapicide pa high level disinfectant without wearing gloves.They reported white marks on their right finger following handling of the disinfectant.Medivators was notified of the reported event through chemtrec.The user facility did not disclose if medical treatment was sought or administered.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL 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 ; 9800 59th avenue n; minneapolis, MN 55442
• MDR Report Key: 12919192
• Report Number: 2150060-2021-00027
• Device Sequence Number: 5645561
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: Lay User/Patient
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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