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

Model Number 10215BL-1

Device Problem Naturally Worn (2988)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Type  Injury  

Event 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
• 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: 16845870
• MDR Text Key: 314321440
• Report Number: 2438477-2023-00037
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 00822383100647
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• 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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2023
• Distributor Facility Aware Date: 04/04/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 05/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male