MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE; ROLLATOR

Model Number 10266HD-BK

Device Problem Defective Component (2292)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's family member, who reported that a "spring came unscrewed," and that when she went to sit on the unit, she fell to the ground[?]due to brake failure." end user reportedly fell and hit her head but did not seek medical attention.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): CC HSING COMPANY LIMITED; no.1, benting; bentsuo villge; sikao township, jiayi county chiayi 62348 ; TW 62348
• MDR Report Key: 15313509
• MDR Text Key: 298826695
• Report Number: 2438477-2022-00081
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383931654
• UDI-Public: 822383931654
• 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: 08/29/2022

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 Model Number: 10266HD-BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female