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

Model Number ML02-0117

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 11/08/2016

Event Type  No Answer Provided  

Manufacturer Narrative

It was reported that facility staff members experienced chemical exposure symptoms from rapicide pa high level disinfectant spill.One staff member went to the er with the following exposure symptoms: headache, burning throat, inhalation discomfort, light headedness, and nausea.Medivators ra spoke with this facility to follow up and it was reported that staff members affected by the rapicide pa spill are well and doing fine.Medivators immediately provided the appropriate sds for handling of the spill.The cause of the spill is unknown.This complaint will continue to be monitored within the medivators complaint handling system.Exposure risks already known.

Event Description

It was reported that facility staff member experienced chemical exposure symptoms from rapicide pa high level disinfectant spill.This staff member went to the er with the following exposure symptoms: headache, burning throat, inhalation discomfort, light headedness, and nausea.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: HIGH LEVEL DISINFACTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 6146053
• MDR Text Key: 61469204
• Report Number: 2150060-2016-00050
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention