MAUDE Adverse Event Report: DOLOMITE DOLOMITE GLOSS 600 ROLLATOR; WALKER, MECHANICAL

Model Number 1655081

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The repair technician advised that he is unable to provide any information about the user or the use/service history of the device.Multiple attempts were made to contact the user without success.This rollator is included in a voluntary recall (z-2445-2023) that was initiated due to an issue identified in the design.It was identified that the dolomite gloss rollators are not operating as intended when used intensely or subjected to external impacts.As a result, the durability of the seat is decreased which can lead to premature failure of the seat's folding mechanism and potential breakage of the crossbar.As part of the recall, customers are being advised to discontinue use of the rollator.

Event Description

A repair technician advised that he has a dolomite gloss 600 rollator from a customer that has a broken seat and cross brace.Pictures of the rollator were provided, confirming the broken components.

• Brand Name: DOLOMITE GLOSS 600 ROLLATOR
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer (Section G): DOLOMITE; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 17844481
• MDR Text Key: 324602021
• Report Number: 9615290-2023-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1655081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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