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

Model Number RTL10266TWHL

Device Problems Device Damaged Prior to Use (2284); Insufficient Information (3190)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 01/02/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator.The end user reported that "the front wheel of his unit is not straight and causes the unit to tip over from time to time," but that he did not notice any problem with the wheel out of the box.Despite noticing the defect, the end user continued to use the device and reported receiving bruises, cuts and a head injury, resulting in an emergency room visit with an x-ray and ct-scan of the cervical spine.Drive attempted but was not able to retrieve the unit for evaluation.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT; no. 589 hualu road; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 14945907
• MDR Text Key: 295423976
• Report Number: 2438477-2022-00043
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383006314
• UDI-Public: 822383006314
• 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: 07/07/2022

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 Operator: Lay User/Patient
• Device Model Number: RTL10266TWHL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2022
• Distributor Facility Aware Date: 01/19/2022
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 06/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 50 KG