MAUDE Adverse Event Report: COMPASS HEALTH BRANDS CAREX; UPLIFT COMMODE ASSIST

Model Number CCFCA200

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

We purchased a bathroom safety chair.I would like to send you a photo of this product.It's a safety hazard, back support brace split.Picture provided shows the frame only (not fully visible), tipped on it's front, bottom crossbar on the back right (facing) is cracked from the bottom and bent downward at the screw to attach the seat.Seat is not attached.Unable to see if backbar is attached, not visible.

• Brand Name: CAREX
• Type of Device: UPLIFT COMMODE ASSIST
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 12280248
• MDR Text Key: 265176160
• Report Number: 3012316249-2021-00025
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CCFCA200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 95