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

Model Number	700-957
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2022-00075
• Device Sequence Number: 5653072
• Product Code: ITJ
• UDI-Device Identifier: 07540212100226
• UDI-Public: 07540212100226
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2022
• Report Date (Section F): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 700-957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG
• Date Report Sent to FDA: 09/13/2022