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

Catalog Number ML02-0117

Device Problem Device Handling Problem (3265)

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

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that a user experienced exposure symptoms after handling rapicide pa high level disinfectant (hld).After unpacking bottles of hld the users' hands turned white and started to itch.The user immediately went to the sink and washed their hands with soap and water as directed by the safety data sheet.The user was not wearing the proper protective equipment when handling the hld bottle.The user did not seek medical attention and is doing fine now.This will continue to be monitored in the medivators complaint handling system.

Event Description

It was reported by the facility that a user experienced exposure symptoms after handling rapicide pa high level disinfectant (hld).

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 14608 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: 8175815
• MDR Text Key: 130778327
• Report Number: 2150060-2018-00079
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ML02-0117
• Device Lot Number: 937796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other