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	12/06/2016
Additional Manufacturer Narrative
Medivators distributor received a call from facility faculty member who reported exposure to rapicide opa-28.They indicated that the facility had a 4 gallon spill, where this faculty member spent 4 hours working in a relatively small area to clean up the spill.The exposure symptoms reported include eyes burning and throat/inhalation conditions related to the extended exposure time.They stated that they were wearing ppe including a mask, but not a respirator.They reported this event to their manager and they referred to the sds on file.Medivators ra followed up and it was reported that no additional medical attention was sought.It was not reported how the spill occured.This complaint will continue to be maintained in medivators complaint system.
Event or Problem Description
The case states that a faculty member experienced burning eyes and throat, and respiratory inhalation exposure symptoms while cleaning up a rapicide opa high level disinfectant spill.

• 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: 6220197
• Report Number: 2150060-2017-00001
• Device Sequence Number: 709803
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K120306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

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 Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 01/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1