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

Model Number RTL10261BL

Device Problem Break (1069)

Patient Problem Head Injury (1879)

Event Date 04/30/2023

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's daughter, who stated that the "leg frame was broken," which reportedly caused the end user to fall off and "hit his head on [a] counter." it is not clear whether the frame was broken during the reported incident, or before.The reporter confirmed that there was no illness, injury or medical treatment associated with the complaint.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.

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's daughter, who stated that the "leg frame was broken," which reportedly caused the end user to fall off and "hit his head on [a] counter." it is not clear whether the frame was broken during the reported incident, or before.The reporter confirmed that there was no illness, injury or medical treatment associated with the complaint.Drive processed a replacement for the end user.Drive 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,; no.39, hengtong road; huashi town, jiangsu 21442 1; CH 214421
• MDR Report Key: 17087151
• MDR Text Key: 316882301
• Report Number: 2438477-2023-00062
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• 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,Followup
• Report Date: 06/08/2023,08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL10261BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 06/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 96 KG