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

Model Number 10257BL-1

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 300049847
• Report Number: 2438477-2022-00095
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 00822383290331
• 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: 09/16/2022,09/15/2022

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