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

Model Number	10257BL-1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who reported that "she received a wound caused by the brake.She was taken by ambulance to the emergency room and treated.She has been treated for three months at wound clinics as well." drive made multiple attempts to retrieve the unit.The end user stated she "will not be able to return the unit" for evaluation.Drive 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: 15438388
• Report Number: 2438477-2022-00095
• Device Sequence Number: 5581675
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 00822383290331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/15/2022
• Report Date (Section F): 09/16/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/28/2022
• Device Age: 1 YR
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/16/2022