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

Model Number ML02-0117

Device Problem Shipping Damage or Problem (1570)

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

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

A delivery driver reported being exposed to rapicide pa high level disinfectant from a damaged box containing a leaking container inside the driver's trailer.The driver reported that upon handling the damaged box he noticed the cap was off the container which caused the hld to come in contact with his hands, clothes, and shoes.After experiencing burning symptoms on his skin from the hld exposure, he called a chemtrec representative who advised him to get to running water and start flushing his skin.Chemtrec contacted the delivery driver's company safety department and provided instructions for cleaning the trailer where the leak occurred and advised on what to do with the damaged freight.The delivery driver reported experiencing burning hands and the skin turning slightly red on his hands and feet.After showering, the burning symptoms went away and no additional medical attention was sought.It is unknown how and when the box of rapicide pa became damaged during shipping, causing the cap to come off the container and leak solution inside the trailer.The orientation of the box during shipping is unknown.Medivators will continue to monitor this complaint within medivators complaint handling system.

Event Description

A delivery driver reported a box of leaking rapicide pa high level disinfectant inside his trailer.Upon picking up the box, he noticed the leaking hld which came in contact with his hands, clothes, and shoes.The delivery driver reported burning symptoms on his hands and observed redness on his hands and feet.

• 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: 6886251
• MDR Text Key: 87199280
• Report Number: 2150060-2017-00041
• 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,other
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/22/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• 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