MAUDE Adverse Event Report: TIDI PRODUCTS, LLC TIDI; DRAPE, SURGICAL, EXEMPT

Model Number	CFI-655
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
C-arm drape immediately ripped open upon applying it to c-arm.

• Brand Name: TIDI
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 23802860
• Report Number: 23802860
• Device Sequence Number: 7686091
• Product Code: PUI
• UDI-Device Identifier: 00618125140428
• UDI-Public: (01)00618125140428(11)250130(17)300130(10)66444800
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025
• Report Date (Section F): 11/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: CFI-655
• Device Catalogue Number: CFI-655
• Device Lot Number: 66444800
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• 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
• Date Report Sent to FDA: 11/19/2025