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

Model Number R726BL

Device Problem Device Maintenance Issue (1379)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/16/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.The unit has been in her possession for 2 years with no maintenance and/or adjustments from the service provider.End user was in bathroom and tripped with the rollator causing her to fall into the bath tub.The fall caused a 50/50 fracture of her #1 lumbar vertebrae.The initial reporter was unsure what if anything is wrong with unit.: it tilts to the left.Pms has been trying to retrieve the unit for evaluation and give end-user a new unit.The initial reporter has not been available for this transaction.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO.; #1, chuangye st; sw industial district; matou eco industry pk, hebei 05604 6; CH 056046
• MDR Report Key: 7318000
• MDR Text Key: 101662825
• Report Number: 2438477-2018-00008
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 03/06/2018,03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2018
• Event Location: Other
• Date Report to Manufacturer: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 64