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

Model Number	10215BL-1
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
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's sister, who reported that "the bearings are worn on the front of rollator," and that "as her brother was using the unit, he fell down," causing him to dislocate his ankle and injure his knee.The end user was reportedly transported via ambulance to a hospital, treated and released, but reportedly returned to the hospital at a later date due to "seizures from stress." she stated that he was taking pain medication and was "in a boot." the end user's sister reports that she will not be able to return the unit for evaluation.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: 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: 16845870
• Report Number: 2438477-2023-00037
• Device Sequence Number: 7546637
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 00822383100647
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/01/2023
• Report Date (Section F): 05/01/2023

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: 10215BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 05/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• 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 Sex: Male
• Date Report Sent to FDA: 05/01/2023