MAUDE Adverse Event Report: STERIS CORPORATION; SURGICAL TABLE CUSHION

Model Number	TABLE PAD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Mattress seam coming undone.

• Brand Name: NA
• Common Device Name: SURGICAL TABLE CUSHION
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley road; mentor OH 44060
• MDR Report Key: 22352642
• Report Number: 22352642
• Device Sequence Number: 18163172
• Product Code: LWG
• UDI-Device Identifier: 00724995163808
• UDI-Public: (01)00724995163808(11)240710
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2025
• Report Date (Section F): 06/24/2025

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: TABLE PAD
• Device Catalogue Number: BF292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• 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: 06/24/2025