MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; ROLLATOR

Model Number 10243

Device Problem Material Integrity Problem (2978)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user, who stated that the "front left leg crumpled under his weight when he sat down on the seat," and he reportedly fell and sustained a bruised arm and scraped knee.The end user confirmed that he did not receive any medical treatment.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): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; no. 63,tongxing east road; yumin community; xiaolan, zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 17165125
• MDR Text Key: 317807004
• Report Number: 2438477-2023-00083
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383138107
• UDI-Public: 00822383138107
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10243
• Device Catalogue Number: 10243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Distributor Facility Aware Date: 05/24/2023
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 07/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 93 KG