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

Model Number RTL10261RD

Device Problem Material Integrity Problem (2978)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who stated that while the end user was "attempting to sit on the rollator" to use it as a chair, "the backrest tube of the rollator suddenly detached from the left side of the backrest," causing [her] to fall backwards out of the rollator" and hit her head on the ground.She was hospitalized for approximately a month, and released to home healthcare.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): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 16294393
• MDR Text Key: 308753854
• Report Number: 2438477-2023-00004
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• 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: 02/02/2023

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: RTL10261RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2023
• Distributor Facility Aware Date: 01/16/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 02/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 105 KG