MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LEATHER EXTENSION SANDAL RIGHT; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1232546
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
It was initially reported by the baxter distributor in israel that during the use of the leather extension sandal accessory use with a p500 surgical table, the patients leg slipped off the sandal during the procedure.It is unknown if an injury occurred with this event as there was no report of injury in the initial report.Follow-up communication with the complainant found that the complainant could not provide any additional details of the event, couldn¿t confirm if an injury occurred, nor had any details of any injury.
Additional Manufacturer Narrative
It was initially reported by the baxter distributor in israel that during the use of the leather extension sandal accessory use with a p500 surgical table, the patients leg slipped off the sandal during the procedure.No injury was reported from this event.Based on the investigation performed on pictures provided by the customer and the review of manufacturing data and similar devices at the plant, the cause can be traced to a handling error.The patient's foot must be positioned correctly and carefully in the sandal.The straps can then be tightened that the foot is firmly embedded in the sandal.Based on the investigation results no further actions are required.
Event or Problem Description
It was initially reported by the baxter distributor in israel that during the use of the leather extension sandal accessory use with a p500 surgical table, the patients leg slipped off the sandal during the procedure.It is unknown if an injury occurred with this event as there was no report of injury in the initial report.Follow-up communication with the complainant found that the complainant could not provide any additional details of the event, couldn¿t confirm if an injury occurred, nor had any details of any injury.

• Brand Name: LEATHER EXTENSION SANDAL RIGHT
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl zeiss strasse 7-9; saalfeld, thuringen 07318 ; GM 07318
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22051506
• Report Number: 3007143268-2025-00040
• Device Sequence Number: 15727293
• Product Code: GDC
• UDI-Device Identifier: 00887761972513
• UDI-Public: (01)00887761972513(11)240617
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 07/03/2025

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: Other
• Device Model Number: 1232546
• Device Catalogue Number: 1232546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown