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

Model Number 10201-1

Device Problem Solder Joint Fracture (2324)

Patient Problem Hip Fracture (2349)

Event Date 08/06/2020

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a walker.We have been unable to retrieve the unit for evaluation.The end-user was walking into the bathroom utilizing the device when the leg broke.She fell.She initially did not seek medical attention.She was eventually diagnosed with a fractured hip.Secondary conversation included mention of a second walker and an incident on the stairs.

• 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: 10538732
• MDR Text Key: 207120076
• Report Number: 2438477-2020-00043
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117348
• UDI-Public: 822383117348
• 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: 09/10/2020,08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10201-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Distributor Facility Aware Date: 08/17/2020
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 09/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 66