MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; ROLLATOR

Model Number	10243
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	05/23/2023
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 that the "front left leg crumpled under his weight when he sat down on the seat," and he reportedly fell and sustained a bruised arm and scraped knee.The end user confirmed that he did not receive any medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; no. 63,tongxing east road; yumin community; xiaolan, zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 17165125
• Report Number: 2438477-2023-00083
• Device Sequence Number: 5757695
• Product Code: ITJ
• UDI-Device Identifier: 00822383138107
• UDI-Public: 00822383138107
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2023
• Report Date (Section F): 06/20/2023

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: 10243
• Device Catalogue Number: 10243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2023
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 07/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• 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: 93 KG
• Date Report Sent to FDA: 06/20/2023