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

Model Number	ML02-0117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown how the disinfectant came into contact with the employee's skin.The duration of the reported skin redness and irritation was not provided.Following the event, the user contacted chemtrec and was provided the rapicide pa part a sds.The employee sought medical attention and a bandage to the affected area was applied.No further medical intervention was required.It is not known if the user was wearing proper ppe at the time of the reported event.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 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
A user facility reported that rapicide pa high-level disinfectant part a splashed on an employee's forearm.The employee experienced redness and raising of the skin.The employee washed the affected area.The employee was reported to be wearing gloves, but it is unknown if other personal protective equipment (ppe) was worn at the time of the exposure.No additional reports of injury were reported.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 12725401
• Report Number: 2150060-2021-00025
• Device Sequence Number: 3991534
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2021

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: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1