MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO. LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	R800KD-BL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who reported that a wheel fell out and caused him to fall, sustaining a torn rotator cuff and thumb ligament, which both reportedly require surgery.The device is being returned for evaluation.Drive will update this report should any additional information become available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO. LTD; no.61 &96 zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 18988926
• Report Number: 2438477-2024-00015
• Device Sequence Number: 19556663
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 822383004228
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024
• Report Date (Section F): 03/27/2024

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: R800KD-BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2024
• Event Location: Home
• Date Report to Manufacturer: 03/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/27/2024