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

Model Number 10210-1

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 315355720
• Report Number: 2438477-2023-00051
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 00822383117379
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10210-1
• Device Catalogue Number: 10210-1
• Was Device Available for Evaluation?: No
• Date Report Sent to FDA: 05/16/2023
• Distributor Facility Aware Date: 04/18/2023
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 05/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 141 KG