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

Model Number	10210-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by an end user's son, who stated that "the locking system failed, resulting in collapse of walker and individual using it." there was no injury reported with the initial complaint, but it was later reported that the end user was hospitalized following the incident, although it is unclear whether the hospitalization resulted from the incident or other unrelated conditions.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
• Common Device Name: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; no. 98, zhaoyi rd; zhaolong community; xiaolan, zhongshan guangdong 52841 4; CH 528414
• MDR Report Key: 16943086
• Report Number: 2438477-2023-00051
• Device Sequence Number: 3613920
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 00822383117379
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2023
• Report Date (Section F): 05/16/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10210-1
• Device Catalogue Number: 10210-1
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2023
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 05/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 141 KG
• Date Report Sent to FDA: 05/16/2023