MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number RTL10266

Device Problem Material Twisted/Bent (2981)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

We did the final quality inspection before delivery.The rollator model passed the static load test & fatigue test that were performed in 2023/05 according to the iso 11199-2:2021.

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated that the "right handle suddenly bent down where the plastic handle meets the metal frame" and reported that her mother lost her balance and broke her leg.The end user was taken to the hospital and underwent a week of treatment for her injuries.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• Manufacturer (Section G): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 17709371
• MDR Text Key: 322925347
• Report Number: 3004034546-2023-00001
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2023

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: RTL10266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female