MAUDE Adverse Event Report: MEDIVATORS RAPICIDE DISINFECTANT; HIGH LEVEL DISINFECTANT

Model Number	ML02-0059
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Discomfort (2330); Chemical Exposure (2570)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators received a report from chemtrec that a user experienced eye exposure while handling rapicide high level disinfectant (hld).The user rinsed their eye for several minutes after the exposure, but still experienced discomfort.Chemtrec conferenced the facility and provided a copy of the medivators rapicide hld safety data sheet (sds).It was not confirmed if the user sought additional medical attention.Medivators ra has made several attempts to follow up with the user, but have not received a response.The medivators sds instructs the user to wear protective gloves/eye/face protection while handling rapicide hld.It is unknown if the user was wearing proper protective equipment (ppe) while handling the product.The current condition of the user is unknown.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators received a report from chemtrec that a user experienced eye exposure while handling rapicide high level disinfectant (hld).

• Brand Name: RAPICIDE DISINFECTANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8777850
• Report Number: 2150060-2019-00053
• Device Sequence Number: 11260933
• Product Code: MED
• UDI-Device Identifier: 00677964034855
• UDI-Public: 00677964034855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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 Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/10/2019
• 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