MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD DRIVE; ROLLATOR

Model Number	R728BL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthc are is the initial importer of the device which is a rollator.We have received photos of the device.It has not been returned for evaluation.Consumer has been utilizing the unit for approximately six (6) years.In the hospital after undergoing an unrelated procedure the device snapped at the crossbar while he was seated.He fell to the floor.He noted that there was initially no pain therefore no followup action.He complained that over time there is increase of back aches and interrupted sleep.He became bed ridden two months later the end-user went to the er.He was diagnosed with a pinched nerve,slipped disc, and a small pelvis fracture.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao zhejiang; 31540 8; CH 315408
• MDR Report Key: 9410298
• Report Number: 2438477-2019-00078
• Device Sequence Number: 3987659
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/04/2019
• Report Date (Section F): 12/04/2019

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: R728BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• 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: Other
• Patient Age: 81 YR
• Patient Weight: 103
• Date Report Sent to FDA: 12/04/2019