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 Problem Skin Discoloration (2074)

Event Date 01/05/2017

Event Type  No Answer Provided  

Manufacturer Narrative

The case states the user came into contact with rapicide pa and experienced chemical exposure symptoms on the skin.It was reported the user flushed skin with water and some discoloration of skin occurred, but no blistering.Medivators corporate safety manager spoke with this facility and provided the sds document for rapicide pa.Current status of affected persons unknown.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The case states the customer came into contact with rapicide pa and experienced chemical exposure symptoms on his/her skin.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis 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: 6291101
• MDR Text Key: 66213366
• Report Number: 2150060-2017-00006
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/31/2017

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
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/31/2017
• 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: Initial
• Patient Sequence Number: 1