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

Model Number ML02-0117

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Two employees exposed to rapicide pa on wrist and hand while handling chemical.Employees both wearing ppe, including gloves and gown.After exposure, employees flushed exposed area at wash station per sds instructions.Minor injuries were reported where the employees sought first aid at their facility.Medivators ra spoke to the director of the facilities of health and safety department and she provided information that the employees are fine now.

Event Description

Employee at facility experienced chemical exposure on their hand and wrist while handling rapicide pa.

• Brand Name: RAPICIDE PA
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS; 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: 7465906
• MDR Text Key: 106660338
• Report Number: 2150060-2018-00031
• 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
• 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

• Date FDA Received: 04/26/2018
• 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: 03/27/2018
• 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