MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDI; EYESHIELD EYEWEAR

Model Number 9210A-100

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

This product is sold as a non-sterile device.A historical complaint review did not reveal any similar complaints as this is the first complaint of this type.There were no reported medical complications as a result of this event.The device history record was reviewed for this lot number, there were no issues or manufacturing non-conformities associated with the manufacture of this product.Despite attempts this product was not returned for evaluation.

Event Description

The glasses fell off and into a wound during the beginning stage of suturing a wound.

• Brand Name: TIDI
• Type of Device: EYESHIELD EYEWEAR
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10836737
• MDR Text Key: 224669972
• Report Number: 2182318-2020-00001
• Device Sequence Number: 1
• Product Code: LYU
• UDI-Device Identifier: 00618125132683
• UDI-Public: 618125132683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/10/2020

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: 9210A-100
• Device Lot Number: 0119T003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• 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