MAUDE Adverse Event Report: TIDI PRODUCTS LLC FACE SHIELD, 1 PIECE, FULL; ACCESSORY, SURGICAL APPAREL

Model Number	TIDIFS96
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested to be returned for evaluation, but has not been received.Therefore, this report is based solely on the information provided by the customer.A device history record (dhr) of the affected lot did not reveal any issues that could have contributed to the reported incident.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
(b)(6).Kv:(b)(6)/tidi rep and (b)(6) end user has 10 cases that black strap has very little "stretch".

• Brand Name: FACE SHIELD, 1 PIECE, FULL
• 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: 15991823
• Report Number: 2182318-2022-00141
• Device Sequence Number: 5636121
• Product Code: LYU
• UDI-Device Identifier: 00618125189472
• UDI-Public: 00618125189472
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: TIDIFS96
• Device Catalogue Number: TIDIFS96
• Device Lot Number: 44581835
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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