MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDITOWER PREASSEMBLED GRABNGO DISPENSER; ACCESSORY, SURGICAL APPAREL

Model Number	9210A-100
Medical Device Problem Code	Shielding Failure (1568)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.The product is not available for review.A review of the device history record for the affected lot did not identify any issues noted that could have contributed to the reported issue.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Historical complaint data review identified no other similar complaints documented for this product in the last 5 years.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file: (b)(4).
Event or Problem Description
Customer reporting a complaint on product#: 9210a-100.Customer states rn on (b)(6) 2025 was providing care to patient in full ppe.This included the tidi eyewear lot#: 4353t200.Bodily fluids from the patient (stool) still managed to get in her eye.

• Brand Name: TIDITOWER PREASSEMBLED GRABNGO DISPENSER
• Common Device Name: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 21453291
• Report Number: 2182318-2025-00015
• Device Sequence Number: 7196439
• Product Code: LYU
• UDI-Device Identifier: 00618125132683
• UDI-Public: 00618125132683
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9210A-100
• Device Catalogue Number: 9210A-100
• Device Lot Number: 4353T200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown