MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; WALKER

Model Number 10211-1

Device Problems Collapse (1099); Failure to Align (2522)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 06/16/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a walker.We have not received the device for evaluation.We will file a follow-up submission when additional information is available.We are filing this report in an overabundance of caution.The device collapsed while in use.The user sustained an injury and was taken to a hospital.Her attorney has advised that an adjustment hole did not line up with a pin on the device.No other information is available.

Event Description

(b)(6) is the initial importer of the device which is a walker.We have not received the device for evaluation.We will file a follow-up submission when additional information is available.We are filing this report in an overabundance of caution.The device collapsed upon initial use while stepping down a six inch curb when exiting the apartment to the sidewalk.The user hit her head on the curb.She sustained bruises to her face and body.She was taken to a hospital.She complained of pain in her ribs.Her attorney has advised that an adjustment hole did not line up with a pin on the device.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road,; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 12216865
• MDR Text Key: 263114677
• Report Number: 2438477-2021-00028
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117386
• UDI-Public: 822383117386
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10211-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2021
• Distributor Facility Aware Date: 06/30/2021
• Device Age: 24 MO
• Event Location: Other
• Date Report to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR