MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO., LTD. DRIVE; ROLLATOR

Model Number RTL10555BL

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/10/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution and to be timely.We will file an update once additional information is received.User was sitting on the unit, making herself breakfast.She was self-ambulating on the rollator in her kitchen.The rear leg snapped near the back rest.She hit her head on the stove/oven.The instructions for use warn that the rollator is not a mobility device.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO., LTD.; xilian development zone; jinsha,; danzao town, foshan 52822 2; CH 528222
• MDR Report Key: 11345191
• MDR Text Key: 232446213
• Report Number: 2438477-2021-00006
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383533414
• UDI-Public: 822383533414
• 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: 02/18/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10555BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Distributor Facility Aware Date: 01/19/2021
• Device Age: 7 YR
• Event Location: Home
• Date Report to Manufacturer: 02/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 123