MAUDE Adverse Event Report: WUXI KANGQIANG INDUSTRIAL DRIVE; ROLLATOR

Model Number RTL10261RD

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of in incident involving a rollator by an end user's daughter, who stated that she "stood up from [her] chair, took a step and it broke." there was no information provided regarding the exact nature of the break.The end user reportedly fell, causing a "knot on her hip" and required an ambulance to assist her.She is currently taking pain medication and receiving physical therapy.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated that she "stood up from [her] chair, took a step with [the rollator] and it broke." the end user reportedly fell, causing a "knot on her hip" and required an ambulance to assist her.She is currently taking pain medication and receiving physical therapy.Drive requested that the unit be returned for investigation, during which it was noted that the rollator showed signs of extreme wear and tear, and it could not be determined whether the break in the leg occurred as a result of and the leg gave out after extended use.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): WUXI KANGQIANG INDUSTRIAL; 145 yipu road; dapu industrial park; yixing,, jiangsu 21420 6; CH 214206
• MDR Report Key: 17320692
• MDR Text Key: 319109717
• Report Number: 2438477-2023-00091
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 822383262772
• 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: 08/18/2023

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: RTL10261RD
• Device Catalogue Number: RTL10261RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2023
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 7 YR
• Date Report to Manufacturer: 08/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female