MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE; ROLLATOR

Model Number R726RD

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Damage to Ligament(s) (1952)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated "she was walking to her mail, and the front wheel got stuck in between the grass and the cement walkway, causing her to fall." she had to use her life alert button and the paramedics came.She injured her shoulder, elbow, and hip, had xrays taken at the er in (b)(6) hospital dignity health.Drive requested the unit be returned for investigation and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 17330368
• MDR Text Key: 319189054
• Report Number: 2438477-2023-00094
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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: 07/14/2023

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: R726RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2023
• Distributor Facility Aware Date: 07/14/2023
• Date Report to Manufacturer: 07/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 96 YR
• Patient Sex: Female
• Patient Weight: 53 KG