MAUDE Adverse Event Report: ROLLATOR TRANSPORT CHAIR

Device Problems Mechanical Problem (1384); Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Headache (1880); Pain (1994); Swelling (2091); Arthralgia (2355)

Event Date 07/12/2016

Event Type  Injury  

Event Description

Pt called to report an adverse event that occurred on (b)(6) 2016 regarding her rollator transport chair.Pt stated that as she was being pushed in her rollator chair, the chair flipped her out, throwing her onto the floor.Pt said although the left wheel was shaky, the rollator chair cannot go over any type of doorway strip and has problems with elevators.Pt stated she had to call an ambulance and spent 9 hours in the er.Pt is suffering form knee pain, body pain, swelling, headache, back pain and bruise.Pt is very upset with the design of this device and would like to see an updated, heavier model.Distributor is (b)(4).

• Brand Name: ROLLATOR TRANSPORT CHAIR
• Type of Device: ROLLATOR TRANSPORT CHAIR
• MDR Report Key: 5798005
• MDR Text Key: 49754185
• Report Number: MW5063445
• Device Sequence Number: 1
• Product Code: IOR
• 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: 07/13/2016

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 54 YR