MAUDE Adverse Event Report: ZHENJIANG ENRICH HEALTH CORPORATION DRIVE; WALKER

Model Number	10220-1WW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	05/17/2023
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, who stated that "the [handle] bar broke on both ends and sheared off " and she reportedly fell and sustained bruising.The end user reported that she has home health aides to tend to her bruising and she will be scheduling an x-ray.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.
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a walker by an end user, who stated that "the [handle] bar broke on both ends and sheared off " and she reportedly fell and sustained bruising.The end user reported that she has home health aides to tend to her bruising and she will be scheduling an x-ray.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): ZHENJIANG ENRICH HEALTH CORPORATION; 1 west jinqiao rd; yumin community xiaolan; jiangsu 21232 1; CH 212321
• MDR Report Key: 17167329
• Report Number: 2438477-2023-00085
• Device Sequence Number: 5757512
• Product Code: ITJ
• UDI-Device Identifier: 00822383901145
• UDI-Public: 822383901145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/10/2023
• Report Date (Section F): 07/10/2023

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: 10220-1WW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2023
• Date Report to Manufacturer: 07/17/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 111 KG
• Date Report Sent to FDA: 07/10/2023