MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9 DRIVE; ROLLATOR

Model Number	795BK
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Codes	Laceration(s) (1946); Fracture, Arm (2351)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.We were notified of the incident by a letter written by the end-user's spouse.We do not expect return of the device for evaluation.A follow-up report will be filed if new information is received.The user was ona cement path in the park when they transitioned the rollator into a transport chair by turning the backrest around, and pulling out the foot rest.He sat down and the caregiver started to push him.At a crack in the sidewalk the wheels locked.The user was thrown off the seat and onto the cement, face first.He suffered a broken nose, 2 black eyes, cuts under his eyes, many bruises and lacerations, and a hit on the head.He was taken by the ems to the hospital where he was treated for lacerations and a broken nose.He remained overnight.Instructions clearly state to "do not use seat when unit is on incline or uneven ground.".

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9; no. 1, chuangye street; southwest industial district; matou ecological industry park, 05604 6; CH 056046
• MDR Report Key: 8828874
• Report Number: 2438477-2019-00044
• Device Sequence Number: 2823893
• Product Code: ITJ
• UDI-Device Identifier: 00822383213491
• UDI-Public: 822383213491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/25/2019
• Report Date (Section F): 07/25/2019

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: 795BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2019
• Device Age: 5 YR
• Event Location: Other
• Date Report to Manufacturer: 07/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• 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: Required Intervention
• Patient Age: 6 YR
• Patient Weight: 86
• Date Report Sent to FDA: 07/25/2019