MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COM. DRIVE; ROLLATOR

Model Number R800BL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/15/2019

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The unit has not been returned for evaluation.End-user got up to go to the bathroom in the middle of the night in the dark and when she got to her rollator.She felt a pinch on her leg.She walked to the bathroom and when she turned the light on she saw that she was bleeding profusely from her leg.She was able to wrap it up but the next day went to her doctor to get it checked out.The doctor recommended she go see a would care specialist who she saw a few days later and has been seeing weekly since.End-user states the brake pad that poked through her skin severed a blood vessel.However, the brakes are hand brakes.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COM.; liaoan village, wanshi town; fuyang district; hangzhou city, 31140 6; CH 311406
• MDR Report Key: 9440931
• MDR Text Key: 172034021
• Report Number: 2438477-2019-00079
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383524108
• UDI-Public: 822383524108
• 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: 12/09/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: R800BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Distributor Facility Aware Date: 11/06/2019
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2019
• 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: 87 YR
• Patient Weight: 34