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

Model Number EU:12070-43-27

Device Problem Break (1069)

Patient Problem Hip Fracture (2349)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

This event in occurred in (b)(6) involving a dolomite futura rollator.Invacare is filing this medwatch due to the dolomite futura rollator is also sold in the u.S.This device was manufactured at invacare rea ab in (b)(6) in august 2014.According to the pictures, it can be confirmed that the left front fork has broke, and came off the rollator with its wheel.The breakage occurred on the upper part of the front fork, and there are some signs of wear on the wheel itself.The affected rollator was older than 7 years at the time of the incident and therefore exceeded its expected service life.According to the user manual; the expected service life of this product is five years when used in accordance with safety instructions, maintenance intervals and correct use.The effective product life cycle can vary according to frequency and intensity of use.Information was received that no maintenance work has been carried out on the rollator since 2015.However, both the user manual and the service manual of the rollator state that maintenance should be done regularly (at least once a year).The user manual also states: "periodically inspect the castors tightness, wear and damage." the service manual includes the following instruction "check that wheels and forks work properly, are free from defects and are well fixed." if additional information becomes available a follow-up will be filed.

Event Description

The patient was using the dolomite futura walker that was purchased on (b)(6) 2014.The patient was walking on cobblestones when the wheel fell off, and the patient fell, fracturing their hip.

• Brand Name: DOLOMITE FUTURA
• 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; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 14645275
• MDR Text Key: 293649685
• Report Number: 9615290-2022-00004
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2022

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: EU:12070-43-27
• Device Catalogue Number: DOLOMITE FUTURA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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