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	Malfunction
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 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: 16900307
• Report Number: 3014644996-2023-00003
• Device Sequence Number: 14817329
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R726BK
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG