MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9 DRIVE; TRANSPORT CHAIR

Model Number RTLFW19RW-RD

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 03/04/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not received the device yet for evalustion.We are filing this report in an over abundance of caution.The end user was being pushed in the device from the hallway to the kitchen when the handles broke causing her to fall.  she hit her head but did not seek medical attention.

• Brand Name: DRIVE
• Type of Device: TRANSPORT CHAIR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9; 1, chuangye st; sw industrial dist; matou eco industry pk, handan city 05604 6; CH 056046
• MDR Report Key: 10028390
• MDR Text Key: 191591632
• Report Number: 2438477-2020-00024
• Device Sequence Number: 1
• Product Code: INM
• UDI-Device Identifier: 00822383246277
• UDI-Public: 822383246277
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: RTLFW19RW-RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2020
• Distributor Facility Aware Date: 03/04/2020
• Device Age: 28 MO
• Event Location: Home
• Date Report to Manufacturer: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 70