MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE; WALKER, MECHANICAL

Model Number R726BK

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 02/18/2024

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident by the end user involving a rollator where the end user lost his balance, fell onto the rollator, and sustained a large laceration on his leg due to the brake assembly.He received 27 staples on the laceration.Drive devilbiss healthcare is requesting the return of the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD; no. 1, chuangye street; southwest industrial district; handan city, hebei 05604 6; CH 056046
• MDR Report Key: 19217488
• MDR Text Key: 341438237
• Report Number: 2438477-2024-00022
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

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: R726BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2024
• Distributor Facility Aware Date: 04/03/2024
• Event Location: Home
• Date Report to Manufacturer: 04/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male