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

Model Number R800KD-BL

Device Problem Mechanical Problem (1384)

Patient Problem Damage to Ligament(s) (1952)

Event Date 03/03/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 338735826
• Report Number: 2438477-2024-00015
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383004228
• UDI-Public: 822383004228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: R800KD-BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2024
• Distributor Facility Aware Date: 03/04/2024
• Event Location: Home
• Date Report to Manufacturer: 03/27/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male