MAUDE Adverse Event Report: OLSEN MEDICAL, LLC OLSEN; EYE SHIELD

Model Number	607000
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a total of (b)(4) boxes of 12 (42,756 units) sold of all lots since 2012 with no additional complaints recorded.The part of the product that touches the skin around the eyes is an adhesive.The (b)(4) states to make sure that the patient does not have an allergy to ekg adhesive.It is most likely that the customer had an allergic reaction to the adhesive on the device.The (b)(4) was provided to the customer and the case is being closed on the customer's end with no further investigation necessary.This can be seen at the initial and final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up will be submitted.
Event or Problem Description
The patient experienced a soft tissue injury after removal of the eye shield.There was no long tern affect on the patient.

• Brand Name: OLSEN
• Common Device Name: EYE SHIELD
• Manufacturer (Section D): OLSEN MEDICAL, LLC; 3230 commerce center pl; louisville KY 40211
• MDR Report Key: 11251234
• Report Number: 3000719969-2021-00001
• Device Sequence Number: 17066782
• Product Code: HOY
• UDI-Device Identifier: 00841785107702
• UDI-Public: 00841785107702
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K852404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 607000
• Device Catalogue Number: 607000
• Device Lot Number: 117891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1