MAUDE Adverse Event Report: COMPASS HEALTH BRANDS FOR CAREX BATHROOM SAFETY RAIL; ADAPTOR, HYGIENE

Model Number B369

Device Problems Break (1069); Unstable (1667)

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

Event Date 05/01/2023

Event Type  Injury  

Event Description

The 4 e-clips used to secure the frame to the legs of the carex bathroom safety rail all broke in 3 pieces at about the same time.I purchased 3 units at the same time and all 12 clips broke allowing the metal section securing the frame to the leg section to fall out resulting in a stability issue with the device.Contacted the maker (compass health) and they said that replacement clips were not available.Reference reports: #mw5118255, #mw5118256.

• Brand Name: BATHROOM SAFETY RAIL
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): COMPASS HEALTH BRANDS FOR CAREX
• MDR Report Key: 17085805
• MDR Text Key: 316780966
• Report Number: MW5118257
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B369
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White