MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT DRIVE; OLLATOR

Model Number RTL10266

Device Problems Device Unsafe to Use in Environment (2918); Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/25/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator on january 25th.The user was using the rollator going down the steps.The brakes were pressed but did not function causing the end-user to fall.The user states that she was holding onto the rollator on the first step while going to the next step with the brakes engaged but the rollator moved, and she fell to the next step.Her physical therapist tried to break her fall, but the handlebar poked her in the side, next to her left breast.He then helped her get into the house and no medical attention was required.The end user sought medical attention on january 28th, through x-ray it was determined that she suffered two broken ribs.No additional information is available currently.The device is intended to be used on even surfaces not traversing steps.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.

Event Description

On (b)(6) 2002, drive devilbiss healthcare was notified of an incident involving a rollator.The end user reported that she was using the rollator going down steps, and that she was holding onto the rollator on the first step while going to the next step with the brakes engaged, but the rollator moved, and she fell to the next step, causing the handlebar to poke her in the side.The device is intended to be used on even surfaces, not steps, which is noted in the rollator's hangtag ("use only on even and solid surfaces.") after the accident, the end user's physical therapist helped her to get inside her house, and she did not seek medical attention.However, she sought medical attention on (b)(6), when an x-ray determined that she had two broken ribs.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.We will update this report with any new information that becomes available.

• Brand Name: DRIVE
• Type of Device: OLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT; 3 shenghui south road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 13656510
• MDR Text Key: 289533175
• Report Number: 2438477-2022-00009
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383288819
• UDI-Public: 822383288819
• 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: 03/07/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10266
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 01/25/2022
• Device Age: 6 MO
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG