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

Model Number 10220-1WW

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 05/17/2023

Event Type  Injury  

Event 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 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
• Type of Device: WALKER
• Manufacturer (Section D): ZHENJIANG ENRICH HEALTH CORPORATION; 1 west jinqiao rd; yumin community xiaolan; jiangsu 21232 1; CH 212321
• MDR Report Key: 17167329
• MDR Text Key: 317530933
• Report Number: 2438477-2023-00085
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383901145
• UDI-Public: 822383901145
• 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,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10220-1WW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2023
• Distributor Facility Aware Date: 05/25/2023
• Date Report to Manufacturer: 07/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 111 KG