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

Model Number ML02-0117

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Discoloration (2074); Chemical Exposure (2570)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

Medivators ra contacted the facility and spoke with management.The facility reported while opening a container of rapicide pa, an employee spilt the chemistry on their hand.The employee experienced chemical exposure symptoms of burning sensation, tenderness and whitening of skin to the back of hand.As well as inhalation exposure symptoms.They immediately washed the skin and went to urgent care for hand and the whiteness remained.The employee reported his sense of smell being affected so was going to seek medical attention for inhaling the chemical.It is unknown if symptoms remain, the facility reported the employee is coming to work and has not said anything else.The employee and facility were not following handling instructions as ppe is required when using this product.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Facility reported employee experienced chemical exposure symptoms after spill on hand.

• Brand Name: RAPICIDE PA
• 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: 6453725
• MDR Text Key: 71526030
• Report Number: 2150060-2017-00014
• Device Sequence Number: 1
• Product Code: FEB
• 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: Notification
• Type of Report: Initial
• Report Date: 04/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• 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