MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD DRIVE; ROLLATOR

Model Number R728BL

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870)

Event Date 09/26/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user who stated she sustained "a broken right wrist, bruised shoulder and possible cracked ribs," for which she received x-rays, but did not describe how the rollator contributed to the injuries.The end user requested a replacement.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: ROLLATOR
• 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: 16888572
• MDR Text Key: 314779483
• Report Number: 2438477-2022-00146
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 00822383233246
• 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: 05/08/2023

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: R728BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2023
• Distributor Facility Aware Date: 09/30/2022
• Event Location: Home
• Date Report to Manufacturer: 05/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 91 KG