MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; ROLLATOR

Model Number 795BU

Device Problem Material Integrity Problem (2978)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/09/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated "her mother was walking out to her car for an appointment and the front caster kicked out from under her and was wobbly causing her to fall and hit her head." she reportedly received an "egg" on her head and went to the hospital.Tests were performed for the head injury, but the results came back negative.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): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road; huashi town; jiangyin city, jiangsu, 21442 1; CH 214421
• MDR Report Key: 15771754
• MDR Text Key: 303426493
• Report Number: 2438477-2022-00113
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 00822383221649
• 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: 11/10/2022

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: 795BU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2022
• Distributor Facility Aware Date: 10/11/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 11/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 88 KG