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

Model Number 10210-1

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 07/10/2017

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a walker.The end-user was walking into her doctor's office when the rear left leg of the walker snapped off causing the end-user to fall backwards.Both the doctor and the receptionist witnessed the fall.No additional information is available.The end-user has retained an attorney.The attorney has advised her to keep the walker.We have images of the broken device.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.96, zhaoyi rd.; dongsheng town; zhongshan city, guangdong ; CH
• MDR Report Key: 6834237
• MDR Text Key: 84124638
• Report Number: 2438477-2017-00073
• 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: 09/01/2017,08/07/2017

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: 10210-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2017
• Device Age: 13 MO
• Event Location: Home
• Date Report to Manufacturer: 09/01/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other