MAUDE Adverse Event Report: DRIVE (DEVILBISS) MEDICAL DEPOT ROLLATOR; MECHANICAL WALKER

Model Number 10257RD-1

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

I have two relative recently purchased drive medical (a (b)(4) company) rollators.Both have the same drive product code: 10257rd-1.On separate occasions i sat down on the seats incorrectly on both rollators (easy to do) and both broke.If i hadn't been able to prevent my fall to the floor, i would most likely have experienced severe spine or hip injuries.I reported this problem to drive via phone and email with no response.Also, i repaired one broken seat to find out why it broke and learned that its base was made of very thin plastic which is easily broken.I also learned how easy it is to sit on the seat in such a way that it can and will easily break.I have photos of the rollators and the broken seat support i repaired.

• Brand Name: ROLLATOR
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): DRIVE (DEVILBISS) MEDICAL DEPOT
• MDR Report Key: 6145179
• MDR Text Key: 61517784
• Report Number: MW5066525
• 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: Patient
• Type of Report: Initial
• Report Date: 12/02/2016

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 Operator: Lay User/Patient
• Device Model Number: 10257RD-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86