MAUDE Adverse Event Report: CC HSING COMPANTY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER

Model Number RTL10266CF

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that the rear wheel fell off, causing her to fall and hit her shoulder and head on the kitchen table.Paramedics responded to the scene but the end user refused to go to the hospital.The end user was eventually diagnosed by her physician with a torn deltoid muscle in her left arm and an injury to her quadricep muscle, and is receiving physical therapy.Drive devilbiss is currently investigating the incident, including attempting to retrieve the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Type of Device: WALKER
• Manufacturer (Section D): CC HSING COMPANTY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer (Section G): CC HSING COMPANTY LIMITED; no. 1, benting; bentsuo village; sikao township, jiayi county chiayi 62348 ; TW 62348
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 18298177
• MDR Text Key: 330112287
• Report Number: 3014273557-2023-00002
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266CF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female