MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR

Model Number GV974HD-BR

Device Problem Fracture (1260)

Patient Problems Bruise/Contusion (1754); Fall (1848); Vertebral Fracture (4520)

Event Date 01/23/2022

Event Type  Death  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's wife, who stated that "he was sitting in the product with the wheel locks engaged when the cross-frame snapped causing him to abruptly collapse downward with the sides closing in on him".The end user was taken to the hospital where he was reportedly diagnosed with bruised ribs and multiple vertebrae fractures.End user died several days later.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & I INDUSTRIES LTD; lian du industry park; le liu town, shunde district; foshan city, guangdong ; CH
• MDR Report Key: 16043199
• MDR Text Key: 306086868
• Report Number: 2438477-2022-00128
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 12/23/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GV974HD-BR
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2022
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 5 YR
• Date Report to Manufacturer: 12/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 130 KG