MAUDE Adverse Event Report: CAREX STEP N REST ROLLATOR WALKER; WALKER, MECHANICAL

Model Number A61700

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

A carex walker that we just obtained for a (b)(6) year old family member had a wrong bracket into which the walker backrest was to be inserted and, as a result, the backrest was unstable and could have resulted in the patient falling backwards off the walker.It was a carex step n rest rollator walker, model a 61700.I contacted the company and they no longer had the correct bracket to replace the wrong one.I also contacted (b)(6) which sold us the walker and advised them not to re-sell this walker if we returned it.Fda safety report id # (b)(4).

• Brand Name: CAREX STEP N REST ROLLATOR WALKER
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 13506752
• MDR Text Key: 285564059
• Report Number: MW5107376
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A61700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White