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

Model Number ML02-0117

Device Problems Component Falling (1105); Chemical Spillage (2894)

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported a nurse experienced chemical exposure to rapicide pa high level disinfectant.It was reported that the bottle of hld fell off a cart, causing the lid to come off and hld to splash onto the employee's clothes, leg, and foot.She reported experiencing mild burning and itching symptoms for a couple minutes.The exposed personnel immediately flushed the exposed skin and wiped with a wash cloth.She reported no lasting symptoms.No further medical treatment was required and the affected personnel is reported to be fine.The safety data sheet was sent to the facility per their request.This complaint will continue being monitored within medivators complaint handling system.

Event Description

The facility reported a closed bottle of rapicide pa high level disinfectant fell off a cart causing the lid to come off and the hld to splash onto a nurse's clothes, leg, and foot.The nurse reported experiencing burning and itching symptoms from the chemical exposure.

• 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: 7101693
• MDR Text Key: 94353972
• Report Number: 2150060-2017-00052
• 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
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: ML02-0117
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other