MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE PA; HIGH-LEVEL DISINFECTANT

Model Number ML02-0117

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

Patient Problems Skin Irritation (2076); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

A facility reported three employees were exposed to rapicide pa part a high level disinfectant prior to disposing of the product.It was reported that they discovered the container with some residual product left inside the container and while disposing of the container in a trash compactor, the three employees came in contact with the hld.After having burning symptoms on their hands, all three employees were treated and no further information was provided regarding their condition.The facility was seeking disposal information from (b)(4) after disposing of the container with the residual product remaining inside.(b)(4) and a medivators regulatory representative informed them of the potential hazard due to the improper disposal.The caller received the product sds and was advised to follow up with the fire department for further assistance regarding the disposal of the product in accordance with their local regulations.While attempts were made, there was no further information provided regarding if the three employees who were exposed to the chemical were wearing proper ppe while handling the product.The product container was destroyed during disposal so product lot information was not available.Medivators sales representative confirmed they will follow up with the facility regarding the proper disposal methods for this product.Medivators will continue to monitor this incident in the complaint handling system.

Event Description

A facility reported three employees were exposed to rapicide pa prior to disposal of the product.All three employees received treatment.Sds was sent to the facility, as they were seeking disposal information.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH-LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6818289
• MDR Text Key: 83605911
• Report Number: 2150060-2017-00036
• 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: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other