MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER

Model Number R726BK

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/05/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who reported that the front wheels continued to move while the brakes were locked.The end user did not fall, but reported that because she continued to hold onto the rollator when it was moving, she experienced a sharp pain in her previously replaced elbow and was diagnosed with a complex fracture and referred to an elbow specialist.Drive devilbiss healthcare is currently investigating the incident, however the end user refused to return 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): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 18253281
• MDR Text Key: 329554083
• Report Number: 3014944996-2023-00009
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• 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: 12/02/2023

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 Model Number: R726BK
• Device Catalogue Number: R726BK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female