MAUDE Adverse Event Report: MEDIVATORS RAPICIDE; LIQUID CHEMICAL STERILANT AND HIGH LEVEL DISINFECTANT

Model Number	ML02-0059
Medical Device Problem Code	Chemical Spillage (2894)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported an individual spilled rapicide high level disinfectant on themselves and experienced chemical exposure on their skin.The exposed individual is reported to be doing fine but the facility requested information on the effects of exposure to rapicide hld.Medivators regulatory affairs provided information related to the effects of exposure to rapicide glutaraldehyde along with the product's safety data sheet.They were also advised to seek medical attention if symptoms persist.Medivators ra made several attempts to contact the facility for further information regarding the exposure and if any symptoms were experienced from the chemical exposure.It is unknown if the exposed individual was wearing proper personal protective equipment (ppe) when the spill occurred.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
The facility reported an individual spilled rapicide high level disinfectant on themselves and experienced chemical exposure to their skin.The facility requested information about the effects of exposure to rapicide hld.

• Brand Name: RAPICIDE
• Common Device Name: LIQUID CHEMICAL STERILANT AND HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7292725
• Report Number: 2150060-2018-00012
• Device Sequence Number: 1029022
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: 00677964034855
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: ML02-0059
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other