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

Model Number 10215BL-1

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Laceration(s) (1946); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user who stated that "three of the wheels broke off after hitting a pothole in the street and they sustained a swollen leg and scratches." the end user was taken to the emergency room to treat her injuries.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
• Type of Device: 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: 16643218
• MDR Text Key: 312302980
• Report Number: 2438477-2023-00020
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10215BL-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Distributor Facility Aware Date: 03/07/2023
• Device Age: 4 MO
• Date Report to Manufacturer: 04/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female