MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN LIFT ASSIST BEACH CHAIR; SUPPORT, PATIENT POSITION

Model Number	A-91501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted technical service to report that allen lift assist beach chair had an issue, cracked fiber board.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.
Additional Manufacturer Narrative
No further information is available on the repair at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
This report is intended to correct b3 event date.The original b3 event date was submitted as (b)(6) 2026, but the correct b3 event date was (b)(6) 2026.

• Brand Name: ALLEN LIFT ASSIST BEACH CHAIR
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25217788
• Report Number: 3006697241-2026-00187
• Device Sequence Number: 9778439
• Product Code: CCX
• UDI-Device Identifier: 00615521004125
• UDI-Public: (01)00615521004125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: A-91501
• Device Catalogue Number: A-91501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: N/A.
• Patient Sex: Unknown