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 04/11/2017

Event Type  Injury  

Manufacturer Narrative

A nurse at the facility reported that while wearing nitrile gloves, rapicide pa high level disinfectant splashed on her hand.She reported the gloves disintegrated and she experienced chemical exposure symptoms of skin discoloration.She called (b)(4) to report the incident.She later contacted medivators ra about the incident.She reported that she sought additional medical attention in which no treatment was provided.Her current condition was reported fine.The appropriate ppe, including chemical resistant gloves, should be worn when working with rapicide pa in accordance with handling instructions and chemical sds.Details of what type of gloves she was wearing is unknown.It is also unknown what other ppe was being worn.This complaint will continue to be monitored in the medivators complaint handling system.Not available for evaluation.

Event Description

An employee at the facility reported chemical exposure symptoms of skin discoloration after rapicide pa high level disinfectant splashed on her hands.

• 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: 6549568
• MDR Text Key: 74582222
• Report Number: 2150060-2017-00023
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/05/2017

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
• 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: 04/11/2017
• Initial Date FDA Received: 05/05/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other