MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Facilities Issue (2935)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported that while an employee was lifting intercept detergent off a shelf, chemistry fell and spilled, splashing onto her face and into her eyes.It was reported the employee was wearing proper protective wear including eye wear and gloves at the time of the incident.The employee was back to work the same day the incident occurred with no symptoms.The exposed personnel is reported to be fine.Medivators regulatory affairs contacted the facility after receiving the chemtrec report.It was reported the employee sought medical attention from a local eye clinic where they flushed her eyes with water and applied chemical dye to determine if any damage was done to her eyes.There was no damage as a result of the exposure to intercept detergent.This complaint will continue to be monitored in medivators complaint system.
Event or Problem Description
The facility reported that while an employee was lifting intercept detergent off a shelf, chemistry fell and spilled, splashing onto her face and into her eyes.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 7594340
• Report Number: 2150060-2018-00042
• Device Sequence Number: 1698907
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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
• Operator of Device: No Information
• Device Model Number: ML02-0106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other