MAUDE Adverse Event Report: HEBEI HEALTH PLUS DRIVE; ROLLATOR

Model Number	R726RD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have received images of the device.We do not expect to get the device back for evaluation.The incident happened at night in her kitchen.She had been standing at sink and reached over to turn the walker around to use it to go into next room.The frame split below the handle.She fell.She hit her head on the wall.She hurt her back, hips, and head and got bruises all over.She had been using the unit for a year and a half only inside since she has another unit for outdoor purposes.She went to the doctor the chiropractor to receive cold lazer treatment to help her with the pain.The doctor also informed her that she might have a torn ligament on her left hand as well as a broken left toe.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTH PLUS; no. 1, chuangye street,; southwest industial district,; matou ecological, industry park 05604 6; CH 056046
• MDR Report Key: 8912921
• Report Number: 2438477-2019-00053
• Device Sequence Number: 10834319
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• Combination Product (Y/N): N
• 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): 08/20/2019
• Report Date (Section F): 08/20/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: R726RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2019
• Device Age: 30 MO
• Event Location: Home
• Date Report to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2019
• 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: 61 YR
• Patient Weight: 101
• Date Report Sent to FDA: 08/20/2019