MAUDE Adverse Event Report: DOLOMITE ROLLATOR FUTURA-600 BLACK; MECHANICAL WALKER (WHEELS & NO WHEELS)

Model Number EU:12070-43-21M

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fracture, Arm (2351)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

Invacare is filing this report because the device is also marketed and sold in the u.S.The device was sold by invacare europe and the event occurred in (b)(6).Invacare europe is conducting the investigation.Additional information and pictures were received from the provider confirming the complaint.The patient was using the rollator while going to throw away the trash.The road is about 50 meters long, and the ground is a somewhat uneven paved road.It can be assumed that this uneven path is used frequently.On the way back from taking out the trash, the left front fork broke causing the fall.Breakage of the front fork may be result of impact and or overload followed by fatigue.The most probable cause of the incident is that the combination of multiple stress factors caused by transportation and usage while carrying a load has been impacting the fork with the consequence of a breakage.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.

Event Description

While the patient was using the rollator, the left front fork broke.The patient fell to the ground and broke their right upper arm.

• Brand Name: ROLLATOR FUTURA-600 BLACK
• Type of Device: MECHANICAL WALKER (WHEELS & NO WHEELS)
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio 343 7 5; SW 343 75
• Manufacturer (Section G): DOLOMITE; box 200; vaxjovagen 303; dio 343 7 5; SW 343 75
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 7679260
• MDR Text Key: 113710618
• Report Number: 9615290-2018-00005
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EU:12070-43-21M
• Device Catalogue Number: 12070-43-21M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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): Required Intervention