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

Model Number 10257RD-1

Device Problem Degraded (1153)

Patient Problems Fall (1848); Swelling/ Edema (4577)

Event Date 06/06/2023

Event Type  Injury  

Event 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
• 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: 17398236
• MDR Text Key: 319840157
• Report Number: 2438477-2023-00098
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10257RD-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2023
• Distributor Facility Aware Date: 06/26/2023
• Device Age: 8 MO
• Date Report to Manufacturer: 07/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 107 KG