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
Based on the initial investigation after pictures review, it has been identified that unauthorized modifications were made to the seat, and the rear brackets were not properly adjusted.After doing test, it has been identified that improper assembly significantly lowers strength (as low as ~54 lb-f compared to >150 lb-f under correct assembly).After completing investigation, raz management team will decide to implement corrective action plan if needed and report to regulatory authorities accordingly.As of now, raz is unable to find conclusive codes asked in section h.So this can be changed in final or updated report.It is hard to find the exact details without completing investigation.
Event or Problem Description
On october 16, 2025, the canadian distributor reported raz that on (b)(6) 2025, a client at the group home sustained a serious injury with a client, (b)(6), 70 years old with development disabilities, involving a commode with front and rear seat opening.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, she is currently having daily care with packing changing, she had a catheter which has been removed.There has been many lifestyle changes due to this incident, her current wheelchair is unusable, needed a new sling.Has switched to bed-bath.

• Brand Name: RAZ-CAT
• Common Device Name: COMMODE MANUAL (RAZ-CAT)
• Manufacturer (Section D): RAZ DESIGN INC.; 135 railside road; toronto, ontario, 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 railside road; toronto, ontario, M3A1B-7 ; CA M3A1B7
• MDR Report Key: 23545334
• Report Number: 3006055387-2025-00002
• Device Sequence Number: 9775568
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: RAZ-CAT
• Device Catalogue Number: Z303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• 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