MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICES DRIVE; ROLLATOR

Model Number	10216BL-1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was not returned for evaluation, however, a photo was provided.The end-user was sitting on the device in the kitchen.She was using her feet to push herself backwards when the wheel snapped.She was transported to the emergency room and diagnoses with a bruised hip.She had no caregiver so was unable to return the unit for evaluation.The device is a rollator and intended as a mobility device that can be used to sit and rest as needed.It is not a transportation device.The instructions for use warn against using the device as a transportation device.Historical complaints data of the same nature was very limited with no trend.Possible root cause for the incident could be the users backward movement while sitting using her feet.This is considered misuse.This will be considered an isolated incident.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICES; 1 chuangye st sw ind dist; matou eco indy pk; handan city, hebei 05604 6; CH 056046
• MDR Report Key: 10791533
• Report Number: 2438477-2018-00084
• Device Sequence Number: 1126105
• Product Code: ITJ
• UDI-Device Identifier: 00822383265254
• UDI-Public: 822383265254
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/05/2020
• Report Date (Section F): 11/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10216BL-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2018
• Device Age: 15 MO
• Event Location: Home
• Date Report to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2020
• 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 Weight: 125
• Date Report Sent to FDA: 11/05/2020