MAUDE Adverse Event Report: DRIVE MEDICAL / COLUMBIA MEDICAL LLC DRIVE MEDICAL NITRO EURO STYLE WALKER ROLLATOR, RED; WALKER, MECHANICAL

Model Number RTL10266

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 07/25/2020

Event Type  Injury  

Event Description

I am (b)(6) years old and i have lumbar radiculitis that greatly limits the function of my right leg.I bought a drive nitro rollator in (b)(6) 2020 to be able to get around.A few days after it arrived as i reached to adjust the brake, my left pinkie got caught in the brake mechanism slicing off a piece of skin about 3/8 of inch long and about 1/8 of an inch wide.I bled profusely.When i couldn't stop the bleeding i called for a nurse; i live in a senior citizen residence with nursing coverage.The nurse was able to reduce the bleeding and applied a bandage.However some bleeding continued for five days and required regular rebandaging.The breaking mechanism on the rollator is partially covered, but there is room to get a finger caught.If the cover were extended about a 1/2 an inch it would not be possible to catch a finger.I would like to have my rollator retrofitted with a cover and i believe they should modify the product for future sales.Fda safety report id# (b)(4).

• Brand Name: DRIVE MEDICAL NITRO EURO STYLE WALKER ROLLATOR, RED
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE MEDICAL / COLUMBIA MEDICAL LLC
• MDR Report Key: 10396225
• MDR Text Key: 202772419
• Report Number: MW5096025
• 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: 08/09/2020

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: RTL10266
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 68