MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; WALKERS

Model Number	10210-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	06/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by an end user, who stated that "he was walking from his bathroom to his bed and the left rear leg snapped" and he reportedly fell and sustained bruising and pain near his lower back.The end user confirmed that there was no medical treatment associated with the complaint.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: WALKERS
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17370552
• Report Number: 2438477-2023-00100
• Device Sequence Number: 3863451
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/21/2023
• Report Date (Section F): 07/21/2023

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: 10210-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2023
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• 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: 91 KG
• Date Report Sent to FDA: 07/21/2023