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

Model Number	795BU
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	01/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated "her mother was walking out to her car for an appointment and the front caster kicked out from under her and was wobbly causing her to fall and hit her head." she reportedly received an "egg" on her head and went to the hospital.Tests were performed for the head injury, but the results came back negative.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
• Common Device Name: 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: 15771754
• Report Number: 2438477-2022-00113
• Device Sequence Number: 20479016
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 00822383221649
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2022
• Report Date (Section F): 11/10/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 795BU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 11/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Date Report Sent to FDA: 11/10/2022