MAUDE Adverse Event Report: ABLE LIFE / STANDER INC. ABLE LIFE SPACE SAVING WALKER; WALKER, MECHANICAL

Model Number 4200-B

Device Problem Break (1069)

Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2021

Event Type  Injury  

Event Description

Walker handle broke causing fall that injured leg.Needs walker to assist walking due to radiation caused damage to spine.Fda safety report id# (b)(4).

• Brand Name: ABLE LIFE SPACE SAVING WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): ABLE LIFE / STANDER INC.
• MDR Report Key: 11731581
• MDR Text Key: 247713185
• Report Number: MW5100994
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/22/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4200-B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 100