MAUDE Adverse Event Report: NOA MEDICAL INDUSTRIES PANACEA 3250 BED W/SAFETY LOCK; LONG-TERM CARE BED

Model Number	1070013BEI
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer declined to provide patient details.
Event or Problem Description
Customer reported that a resident at care facility had a skin tear that needed 37 stitches allegedly caused by an exposed opening for an expansion kit on a long-term care bed frame.Customer has yet to provide patient details.Manufacturer sending replacement plastic end caps to cover the opening.We are reporting wit the information provided out of an abundance of caution.

• Brand Name: PANACEA 3250 BED W/SAFETY LOCK
• Common Device Name: LONG-TERM CARE BED
• Manufacturer (Section D): NOA MEDICAL INDUSTRIES; 801 terry lane; washington MO 63090
• Manufacturer (Section G): NOA MEDICAL INDUSTRIES; 801 terry lane; washington MO 63090
• Manufacturer Contact: melvin archie, iii ; 801 terry lane; washington, MO 63090 ; 6362316031
• MDR Report Key: 24214929
• Report Number: 1931947-2026-00001
• Device Sequence Number: 8326362
• Product Code: FNL
• UDI-Device Identifier: 00817492011601
• UDI-Public: 00817492011601
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1070013BEI
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2016
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown