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

Model Number ML02-0117

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

Patient Problem Chemical Exposure (2570)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Biomed at the facility reported experiencing lasting exposure symptoms of a burning throat and watery eyes after working with rapicide pa.She reported her symptoms lasted a couple days.Medivators ra spoke to her and she reported not wearing a mask at the time as recommended by the sds.She reported to be fine after a couple days.This will be continued to be monitored in the medivators complaint system.

Event Description

Biomed at the facility reported experiencing lasting exposure symptoms of a burning throat and watery eyes after working with rapicide pa.She reported her symptoms lasting two to three days.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: RAPICDE PA
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis,
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; minneapolis 55447 ; 7635533349
• MDR Report Key: 7470541
• MDR Text Key: 106831170
• Report Number: 2150060-2018-00033
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964063619
• UDI-Public: 00677964063619
• Combination Product (y/n): N
• 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: 04/26/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/27/2018
• 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): Other