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

Model Number 10210-1

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 06/11/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 319486220
• Report Number: 2438477-2023-00100
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10210-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2023
• Distributor Facility Aware Date: 06/23/2023
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG