MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; 3 WHEEL ROLLATOR

Model Number RTL199

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Head Injury (1879)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who reported that she "was walking with [rollator] and brake cables were sticking out, which caused her to fall and hit her head." 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: 3 WHEEL 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: 15311818
• MDR Text Key: 298797336
• Report Number: 2438477-2022-00077
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383000701
• UDI-Public: 822383000701
• 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: 08/29/2022

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 Model Number: RTL199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1