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

Model Number	FL36
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
User contacted the technical service department of the manufacturer mentioning that a siderail arm cover, at the right head of the bed, was broken.It was further reported that a patient while exiting the bed, scratched her skin on the damaged component.

• Brand Name: OOK SNOW
• Common Device Name: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, 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: 12843748
• Report Number: 3009591865-2021-00023
• Device Sequence Number: 17231565
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 010067048200006711170330
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: FL36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown