MAUDE Adverse Event Report: RAZ DESIGN INC. RAZ-CAT; COMMODE MANUAL (RAZ-CAT)

Model Number	RAZ-CAT
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Test conclusion suggests that there is no risk of front seat brackets breaking under intended use as per instructions provided.However, to enhance customer safety, frame savers will be added to all new far seats and retrofit kits will be provided to existing customers.
Event or Problem Description
On (b)(6) 2025, the raz canadian distributor reported raz that on (b)(6) 2025, a client at the group home sustained a serious injury involving a commode.After assisting the client with a shower and returning her to the bedroom, staff noticed she had partially fallen into the commode opening.As staff prepared to reposition her, the commode seat snapped, causing the client to fall through and suffer a rectal impalement injury.Staff placed the client on her side and held her in position until emergency health services (ehs) arrived.Ehs had to cut the commode to facilitate safe transport to the hospital.Because of the commode seat snapped, client fell through and suffer a rectal impalement injury.Group home staff placed the client on her side and held her in position until emergency health services (ehs) arrived.Ehs had to cut the commode to facilitate safe transport to the hospital.(b)(6) was in the hospital for 3 weeks,.

• Brand Name: RAZ-CAT
• Common Device Name: COMMODE MANUAL (RAZ-CAT)
• Manufacturer (Section D): RAZ DESIGN INC.; 135 raildside road.; toronto, canada, M3A 1 B7; CA M3A 1B7
• Manufacturer (Section G): RAZ DESIGN INC.; 135 raildside road; toronto, ontario, M3A 1 B7; CA M3A 1B7
• Manufacturer Contact: arslan rahat ; 135 raildside road.; toronto, canada, M3A 1-B7 ; CA M3A 1B7
• MDR Report Key: 23796837
• Report Number: 3006055387-2025-00003
• Device Sequence Number: 16070077
• Product Code: INN
• UDI-Device Identifier: 00628758003038
• UDI-Public: 00628758003038
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: RAZ-CAT
• Device Catalogue Number: Z303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White