MAUDE Adverse Event Report: TIDI PRODUCTS LLC CARD RESP EYESHIELD P-ASMB; ACCESSORY, SURGICAL APPAREL

Model Number	CAHEYEWEAR
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 historical complaint data identified two similar complaints in the past three years related to incorrect dimensions or fit, resulting in a complaint rate of (b)(4).Recent communication with the manufacturing site confirmed that no additional concerns or related feedback have been reported.Based on the current investigation and available evidence, the issue appears to be the result of improper application rather than a product design deficiency.While size selection could be a contributing factor, the investigation is still ongoing, and no definitive conclusions have been reached at this time.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
The product is too small.Incident involved a surgeon performing a procedure and the item popped off of his head into the sterile field.

• Brand Name: CARD RESP EYESHIELD P-ASMB
• 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: 22186548
• Report Number: 2182318-2025-00057
• Device Sequence Number: 8690574
• Product Code: LYU
• UDI-Device Identifier: 20885380070621
• UDI-Public: 20885380070621
• Combination Product (Y/N): N
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: CAHEYEWEAR
• Device Catalogue Number: CAHEYEWEAR
• Device Lot Number: UNKNOWN
• 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: 05/13/2025
• Initial Report FDA Received Date: 06/11/2025
• 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