MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO LTD DRIVE; ROLLATOR

Model Number 795BU

Device Problem Unintended Movement (3026)

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

Event Date 06/01/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.A follow up will be submitted when additional information is available.The device moved unexpectedly while the user was getting out of f bed to use the restroom.The report stated that the brake failed to lock the wheels.The user fell to the floor and was bruised.She was taken to the hospital the next morning when she could not move.She was kept there for three days.Nothing was found to be broken.Her family plans to get her physical and occupational therapy.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO LTD; 3 shengrui south road; nntou town; zhongshan city, guangdong ; CH
• MDR Report Key: 12497546
• MDR Text Key: 273082924
• Report Number: 2438477-2021-00047
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 822383221649
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/20/2021,09/10/2021

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: 795BU
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2021
• Distributor Facility Aware Date: 09/10/2021
• Device Age: 15 MO
• Event Location: Home
• Date Report to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR
• Patient Weight: 42