MAUDE Adverse Event Report: UMANO MEDICAL INC OOK SNOW; HOSPITAL BED

Model Number	FL36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Laceration(s) (1946)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Umano initiated an investigation upon receiving the complaint, which included photos from the reporter.We requested the dimensions of the mattress/bolster and the model used on the bed at the time of the incident.After reviewing all the information and comparing it with a similar bed with a similar configuration, we found no evidence of product failure.However, the customer noted that the patient has a specific clinical condition including neuropathy in the feet, being ambulatory, and having generalized weakness.Based on our investigation, it appears that the patient's clinical condition may have contributed to the incident.No product failure was identified.
Event or Problem Description
On february 25, 2025, customer reported to umano medical's technical service that a patient was found with their foot entrapped between the bolster and the footboard of the bed, resulting in a toe fracture and laceration.He mentioned that the bed is equipped with an mdf(wood) footboard.On february 27, 2025, umano was notified by its us agent of the voluntary medical device report (mdr) number mw5162038 related to the same complaint.

• Brand Name: OOK SNOW
• Common Device Name: HOSPITAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: saoussen gammoudi ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 21706504
• Report Number: 3009591865-2025-00008
• Device Sequence Number: 21350136
• Product Code: FNL
• UDI-Device Identifier: 00670482000685
• UDI-Public: 010067048200068511231025
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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?: No
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 10/26/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown