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

Model Number R726RD

Device Problem Collapse (1099)

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

Event Date 08/01/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user who stated that they were "outside smoking sitting on rollator and went to stand up and the unit folded on them causing him to fall onto the rollator and bent the frame." the end user was injured on his elbow and went to the doctor for medical treatment.Drive made several attempts to retrieve the product for evaluation.Drive will continue to monitor complaints for any related trends.

• 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: 16861014
• MDR Text Key: 314468096
• Report Number: 2438477-2022-00147
• 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: 05/03/2023

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: 05/03/2023
• Distributor Facility Aware Date: 10/04/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 05/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 116 KG