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

Model Number	R800BK
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.(b)(4) was informed of the incident by an attorney who has since dropped the investigation.We do not forsee acquiring the rollator for examination.End-user resided home alone.She had health issues that required her to take coumadin, a blood thinning medication.She was using the rollator to get up from the couch to retrieve a blanket on a nearby sofa.The inside of her right leg came into contact wiith a sharp metal tab thae was part of the brake system.She suffered a serious laceration.The laceration required stitches, wound care and an inpatient stay at the hospital.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT LIMITED COMP; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 8445265
• Report Number: 2438477-2019-00010
• Device Sequence Number: 354478
• Product Code: ITJ
• UDI-Device Identifier: 00822383548579
• UDI-Public: 822383548579
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019
• Report Date (Section F): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R800BK
• Device Catalogue Number: R800BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2019
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 88 YR
• Date Report Sent to FDA: 03/21/2019