MAUDE Adverse Event Report: STERIS CORPORATION; TABLE PAD

Model Number	TABLE PAD
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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
During steris's review of maude, it was found that a user facility reported via maude report #: (b)(4) that their "mattress seam coming undone".No report of injury.
Additional Manufacturer Narrative
Maude report #: (b)(4) did not provide customer contact information.As the maude report did not provide contact information, steris is unable to obtain additional event information and determine the cause of the reported event.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.

• Brand Name: NA
• Common Device Name: TABLE PAD
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22803607
• Report Number: 1043572-2025-00075
• Device Sequence Number: 8960051
• Product Code: LWG
• UDI-Device Identifier: 00724995163808
• UDI-Public: (01)00724995163808(11)240710
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: TABLE PAD
• Device Catalogue Number: BF292
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown