MAUDE Adverse Event Report: MEDIVATORS RAPICIDE OPA-28; HIGH LEVEL DISINFECTANT

Model Number	ML02-0127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A doctor reported treating a patient who was splashed in the eye with rapicide opa-28 high level disinfectant while cleaning endoscopes.The doctor contacted chemtrec emergency services to obtain further information about the product and for consultation regarding treatment of the patient.Chemtrec connected the doctor with rocky mountain poison and drug safety for additional medical assistance.Medivators regulatory followed up with the doctor and the patient reported to the doctor that they experienced eye irritation and rinsed out their eyes after the chemical exposure.The doctor performed testing (ph and fluorescein) and the results came back normal.The patient was prescribed antibiotics and referred to an ophthalmologist.It is unknown if the patient was wearing proper personal protective equipment (i.E.Eye protection) when the incident occurred.There is no information on the identity of the patient/scope technician or their current status.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A doctor reported treating a patient who was splashed in the eye with rapicide opa-28 high level disinfectant while cleaning endoscopes.

• Brand Name: RAPICIDE OPA-28
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 9257403
• Report Number: 2150060-2019-00067
• Device Sequence Number: 14074966
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: ML02-0127
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/30/2019
• 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