MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDI EYESHIELD EYEWEAR ASSORTED COLORS; ACCESSORY, SURGICAL APPAREL

Model Number 9210A-100US

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

Patient Problem Rash (2033)

Event Type  malfunction  

Event Description

The item # is 9210a-100us, the lot # on the box on our shelf is 2150t042- i am not sure that is the lot # of all the ones in the room dispensers, but i wanted to start somewhere.We had two staff members break out in rash around the eye area recently.They were wearing your eye shields.Has something changed in your product?.

Manufacturer Narrative

Device evaluated by mfr: product is not available for evaluation.Therefore, this report is based solely on customer-provided information.Historical complaint data review identified no other similar complaints documented for this product in the last 5 years.This appears to be an isolated incident.The customer had reported having used this product for quite some time with no similar issues reported previously.Additional information was requested regarding the use of the device and the location and severity of the rash; however no response was received.The customer provided lot information for the box in the room at the time that the complaint was reported but could not confirm that the units involved in the incident were from that box.The device history record for this lot was reviewed and identified no nonconformances or other failures identified that could have contributed to the reported issue.All reviewed samples passed inspection prior to release for distribution.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As a part of the 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).

• Brand Name: TIDI EYESHIELD EYEWEAR ASSORTED COLORS
• Type of Device: 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: 15316634
• MDR Text Key: 305510249
• Report Number: 2182318-2022-00105
• Device Sequence Number: 1
• Product Code: LYU
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9210A-100US
• Device Catalogue Number: 9210A-100US
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other