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

Model Number ML02-0117

Device Problem Off-Label Use (1494)

Patient Problem Chemical Exposure (2570)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

It was reported an employee at the facility experienced exposure symptoms after handling rapicide pa.The employee called medivators customer care and reported after picking up a cap for rapicide pa they experienced tingling and burning on their thumb and middle finger.The employee reported the two fingers turned white and flushed the affected area with water.Medivators ra followed up with the employee and supplied the safety data sheet.The employee was not wearing proper protective equipment.The medivators safety data sheet, instructions for use and label instructs the users to wear protective gloves when handling rapicide pa.The employee stated after a few hours her fingers were fine and no longer had exposure symptoms.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

It was reported an employee at the facility experienced exposure symptoms after handling rapicide pa.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8586508
• MDR Text Key: 144278273
• Report Number: 2150060-2019-00037
• 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 Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/07/2019

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
• Device Operator: No Information
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other