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

Model Number ML02-0117

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported a spill of rapicide pa part a.The facility reported following sds directions for cleanup, ventilated the room, and decontaminated the area.It was reported 8 employees complained of brief throat and eye irritation.They were assessed on a first aid basis.No additional medical attention was sought.The current condition of exposed personnel was reported to medivators as fine.This incident did not result in a serious injury, but could potentially lead to injury or illness.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

Facility reported chemical exposure symptoms of brief throat and eye irritation caused by spill of rapicide pa part high level disinfectant.

• Brand Name: RAPICIDE PA PART A
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6373991
• MDR Text Key: 68963958
• Report Number: 2150060-2017-00011
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other