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

Model Number	R726BK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user who stated, "the backrest bracket broke sending him to the floor." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Attempts were made to retrieve the product for investigation.The end user is unable to return the unit for investigation and doesn't have anyone who can assist him.A full replacement was sent to the end user.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no 1 jinzhao st, west district; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 16864812
• Report Number: 2438477-2023-00043
• Device Sequence Number: 5805979
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 00822383240664
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023
• Report Date (Section F): 05/03/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R726BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2023
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 05/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 05/03/2023