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

Model Number R728BL

Device Problem Unintended System Motion (1430)

Patient Problem Fall (1848)

Event Date 10/04/2021

Event Type  Injury  

Event Description

From drive devilbiss: drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report to be timely.We will submit a follow-up when additional information becomes available.While in use the brakes failed to lock and the user fell.He sought medical attention.No further information is available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• 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: 13658238
• MDR Text Key: 286506015
• Report Number: 3014644996-2022-00011
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• 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: Other
• Type of Report: Initial
• Report Date: 03/03/2022

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: R728BL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/03/2022
• 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 Sex: Male