MAUDE Adverse Event Report: DOLOMITE DOLOMITE FUTURA 520; WALKER, MECHANICAL

Model Number DOLOMITE FUTURA 520

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

On october 23, 2023, invacare was made aware of an event that occurred in finland involving a dolomite futura 520 rollator.Invacare is filing this medwatch in an abundance of caution due to the dolomite futura 520 rollator was also sold in the u.S by clarke healthcare.This device was manufactured at invacare rea ab in sweden in 2022.The dealer evaluated the rollator and noted the wheels are worn and the left brake slides, otherwise, the device appeared fine.Neither of the findings appeared to cause or contribute to the incident.At this time, it appears that the incident was caused by the wheel getting stuck in a groove in the road causing the user to fall over the rollator.The device has not been returned to invacare.The dolomite futura/dolomite symphony rollator user manual (1543649-d) states the walking aid is suitable for outdoor use on even ground.The user manual also recommends to ensure performance and safety, to inspect the product regularly which includes the wheels¿ tightness, wear and damage.

Event Description

The customer stated the caster on futura 520 rollator went into a groove in the street and the customer fell.The customer stated has received wounds to the face and elbow, requiring stitches.

• Brand Name: DOLOMITE FUTURA 520
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer (Section G): DOLOMITE; box 200; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18162054
• MDR Text Key: 328425517
• Report Number: 9615290-2023-00003
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DOLOMITE FUTURA 520
• Device Catalogue Number: DOLOMITE FUTURA 520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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