MAUDE Adverse Event Report: GRAHAM - FIELD LUMEX 4 WHEEL ROLLATOR

Device Problem Crack (1135)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/25/2015

Event Type  Injury  

Event Description

Wheel of rollator has plastic and broke/cracked/shattered when resident used the seat of the rollator to sit on to rest.When wheel broke/cracked/shattered resident fell backwards hitting his elbow on the facility brick wall causing injury to his left elbow.On (b)(6) /2015, resident was transported to (b)(6) hospital for eval of deformation of left elbow and resident's complaints of acute pain, hospital emergency room doctor referred resident to orthopedic specialist due to the findings of a fracture to left elbow.On 07/13/2015, resident was seen by (b)(6) for f/u from (b)(6) hospital emergency room of a fractured left elbow.Attending physician at (b)(6) completed xrays and completed an eval of resident's left elbow.Their findings were displaced acute fracture to left proximal ulna, chronic left radial head fracture.They requested resident obtain surgical clearance from his pcp for radial head placement and pins into ulna fracture.07/14/2015, resident was seen by his pcp to obtain surgical clearance for radial head placement and pins into ulna fracture.An ekg was complete in pcp office which had abnormal readings.Resident has at this point referred to a cardiologist, pcp gave orders to obtain labs and a chest xray to be completed.On (b)(6) 2015, resident was taken to (b)(6) hospital for chest xray and labs to be completed.On (b)(6) 2015, dr (b)(6), received residents ekg readings as well as history on resident.He did not wish to complete an eval of resident due to him agreeing with pcp findings and he felt no further assessment was needed by him and would allow the clinical surgeon to make the final decision regarding surgery.On 07/20/2015, resident followed up with clinical surgeon at (b)(6), dr.(b)(6), for eval surgical clearance for radial head placement and pins.Dr.(b)(6) decided to plan for surgery on (b)(6) 2015.

• Brand Name: LUMEX 4 WHEEL ROLLATOR
• Type of Device: ROLLATOR
• Manufacturer (Section D): GRAHAM - FIELD
• MDR Report Key: 4974765
• MDR Text Key: 6083910
• Report Number: MW5045131
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Age: 64 YR
• Patient Weight: 102