MAUDE Adverse Event Report: DOLOMITE ROLLATOR FUTURA-600 BLACK BY10; WALKER, MECHANICAL

Model Number EU:12070-43-21M

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/10/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u.S.The device was not returned to invacare europe, information and pictures were received from the provider confirming the complaint.The device is 5 years and 9 months old, the expected service life of the rollator is five years when used in accordance with safety instructions, maintenance intervals and correct use, stated in the user manual.The effective product life cycle can vary according to frequency and intensity of use.Should additional information become available, a supplemental record will be filed.

Event Description

While walking indoors, the front wheel fell off of the futura 600 rollator.The user fell to the floor causing a broken femur which required surgery.

• Brand Name: ROLLATOR FUTURA-600 BLACK BY10
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; dio 343 7 5; SW 343 75
• Manufacturer (Section G): DOLOMITE; box 200; dio 343 7 5; SW 343 75
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8150763
• MDR Text Key: 129910070
• Report Number: 9615290-2018-00008
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EU:12070-43-21M
• Device Catalogue Number: 12070-43-21M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR