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

Model Number 10233

Device Problem Material Twisted/Bent (2981)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/18/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a walker by an end user, who stated that "the leg of the unit bent and caused the end user to fall and sustain a fractured rib." 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
• Type of Device: WALKER
• 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: 16043313
• MDR Text Key: 306089330
• Report Number: 2438477-2022-00117
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2022

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: 10233
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2022
• Distributor Facility Aware Date: 11/28/2022
• Date Report to Manufacturer: 12/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male