MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO., LTD DRIVE; ROLLATOR

Model Number 700-957

Device Problem Defective Component (2292)

Patient Problem Fall (1848)

Event Date 06/29/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified by an end user of an incident involving a rollator.The end user reported that "the arms are not secured to my chair," and that "one of the rubber arms came off and i broke my collar bone." the end user reported going to the emergency room.The end user reported that he was "not able to return the unit" for evaluation.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): SICHUAN AST MEDICAL EQUIPMENT CO., LTD; no.58 ,jin-peng road; c area, luxian industrial park; luzhou city, sichuan 64610 0; CH 646100
• MDR Report Key: 15411990
• MDR Text Key: 299788484
• Report Number: 2438477-2022-00075
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 07540212100226
• UDI-Public: 07540212100226
• 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: 09/13/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700-957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Device Age: 2 YR
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG