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

Model Number R728BL

Device Problem Material Fragmentation (1261)

Patient Problem Fall (1848)

Event Date 08/28/2018

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao zhejiang; 31540 8; CH 315408
• MDR Report Key: 9410298
• MDR Text Key: 169265836
• Report Number: 2438477-2019-00078
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233246
• UDI-Public: 822383233246
• 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: 12/04/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: R728BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2019
• Distributor Facility Aware Date: 09/11/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 103