MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETEGENT; ENDOSCOPE DETERGENT

Model Number ML02-0106

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

Patient Problem Chemical Exposure (2570)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported an employee experienced chemical exposure to the eye.The employee was wearing a mask and ppe.It was reported the liquid splashed over the protective equipment and got into her eye.The employee immediately flushed eyes with water.The facility reported following the directions on the sds.Medivators ra contacted the facility in response to a chemtrec report.The facility reported the employee did not seek additional medical attention or experience any further symptoms.Current condition of employee is reported to be fine.This event could potentially lead to user or patient illness or injury.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Facility reported an employee experience chemical eye exposure to intercept detergent.

• Brand Name: INTERCEPT DETEGENT
• Type of Device: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447 ; 7632487189
• MDR Report Key: 6458179
• MDR Text Key: 71679665
• Report Number: 2150060-2017-00017
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/04/2017

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: ML02-0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/04/2017
• 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