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

Model Number	10200-1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.This report is filed as result of a regression analysis.End-user was prescribed the walker after undergoing surgery.She could not bear weight on her left foot.She was "hopping" with the walker at night when the walker leg bent backwards she fell forwards and hit her head on the dresser.She was unconscious and awoken by her daughter.The end-user refused to go to the hospital.She sustained a black eye.The walker was replaced by a crutch at the beest of her daughter.After the surgery her caretaker noted that the patient could not use the walker in the proper manner since she could not bear weight on her left foot.The device was 3 days old.Analysis of the cause of the device malfunction was due to the device not being used as intended.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi rd,; dongsheng town; zhongshan city, guangdong
• MDR Report Key: 10146388
• Report Number: 2438477-2018-00069
• Device Sequence Number: 2924852
• Product Code: ITJ
• UDI-Device Identifier: 00822383117331
• UDI-Public: 822383117331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2020
• Report Date (Section F): 06/11/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10200-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/14/2018
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/11/2020