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

Model Number DOLOMITE

Device Problem Break (1069)

Patient Problem Concussion (2192)

Event Date 02/26/2022

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 (b)(4) in august 2006, and has been used by three different patients over the years.With the available information we are unable to determine the cause of the incident.We are awaiting the return of the device, the complaint will be updated when more information is available.

Event Description

The end-user was going for a walk using a futura rollator.Suddenly the front wheel of the rollator broke, and the patient fell.They were helped up, and sat on the rollator and the other front wheel also broke.As a result, the end-user suffered a mild concussion as well as marks on the body.A local nurse treated a small scratch.

• Brand Name: DOLOMITE FUTURA ROLLATOR 520
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen; diö 34375 ; SW 34375
• Manufacturer (Section G): DOLOMITE; box 200; växjövägen 303; diö 343 7 5; SW 343 75
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 14015670
• MDR Text Key: 288617470
• Report Number: 9615290-2022-00002
• 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: 03/07/2022

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: DOLOMITE
• Device Catalogue Number: DOLOMITE FUTURA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• 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): Other
• Patient Weight: 60 KG