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 Irritation (1941); Tingling (2171); Chemical Exposure (2570)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The chemtrec respondent reported that a caller from (b)(6) medical center was treating a patient who had their skin exposed to rapicide pa high-level disinfectant.The affected patient had been exposed to the chemical and experienced irritation and tingling to the exposed area of their skin.Treatment included flushing the exposed area with copious amounts of water.The manufacturer sds was provided to the facility for treatment instructions.Medivators regulatory affairs has made multiple attempts to contact this facility with no success of getting ahold of the initial reporter.It is unknown if appropriate ppe was worn when the incident occurred.This complaint will continue to be monitored within medivators complaint system.

Event Description

Medivators received a chemtrec report which stated a patient at a medical facility, who was exposed to rapicide pa disnfectant product, was experiencing tingling and irritation on their skin.

• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6509144
• MDR Text Key: 73330793
• Report Number: 2150060-2017-00018
• 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: other,user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ML02-0117
• Date Manufacturer Received: 03/21/2017
• 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
• Patient Outcome(s): Hospitalization