MAUDE Adverse Event Report: ZHONGSHAN LEBORN MEDICAL COMPANY LIMITED DRIVE; ROLLATOR

Model Number 10289BL

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a rollator.End-user awoke to use the restroom.She used her device.When she was walking back in the restroom the rollator collapsed on her.She fell into the glass shower wall.She ended up breaking both her femur and knee cap and getting 64 stitches.The unit is on its way back for evaluation.We will file an updated submission when evaluation is completed.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN LEBORN MEDICAL COMPANY LIMITED; chuang zhan rd.,; xinsheng industrial; area, no.72, dong chen road, 52841 4; CH 528414
• MDR Report Key: 8769476
• MDR Text Key: 150385343
• Report Number: 2438477-2019-00034
• 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: 07/08/2019

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: 10289BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2019
• Distributor Facility Aware Date: 06/17/2019
• Device Age: 24 MO
• Event Location: Home
• Date Report to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 68