MAUDE Adverse Event Report: MEDIVATORS RENALIN 100 COLD STERILANT; MEDICAL DEVICE DISINFECTANT

Model Number	78397-846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported an employee splashed renalin 100 cold sterilant on their hand.The employee did not initially realize until he noticed a dime-size white spot on his finger.Medivators ra followed up with the employee at the facility in response to the chemtrec report.The employee reported rinsing his finger for about thirty minutes and the symptoms went away.The employee reported wearing dry latex gloves, and does not know how the chemical reached his skin.No additional medical attention was sought and the employee's current condition is fine.This event could potentially lead to illness or injury.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Facility reported an employee splashed renalin 100 on hand and experienced chemical exposure symptoms such as discoloration of the skin of his fingers.

• Brand Name: RENALIN 100 COLD STERILANT
• Common Device Name: MEDICAL DEVICE DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6458160
• Report Number: 2150060-2017-00015
• Device Sequence Number: 10916247
• Product Code: LRJ
• UDI-Device Identifier: 00677964011740
• UDI-Public: 00677964011740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K941439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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: 78397-846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2017
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other