MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; ROLLATOR

Model Number	10257RD-1
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fall (1848); Swelling/ Edema (4577)
Date of Event	06/06/2023
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, who stated that the "front right wheel exploded." there was no further information provided regarding the specific nature of the defect.The end user reportedly fell and experienced some pain and swelling in his elbow, for which he treated in an emergency room approximately one week later.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17398236
• Report Number: 2438477-2023-00098
• Device Sequence Number: 5921943
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2023
• Report Date (Section F): 07/26/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10257RD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Device Age: 8 MO
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Date Report Sent to FDA: 07/26/2023