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

Model Number DOLOMITE GLOSS 600

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

On december 19, 2023, invacare was made aware of this event that occured in france involving a dolomite gloss 600 rollator.Invacare is filing this medwatch in and abundance of caution due to the dolomite gloss 600 rollator is also sold in the u.S.And is a subject of field correction z-2445-2023.This device was manufactured at invacare rea ab in sweden in 2021, and the serial number falls in the range of the field correction.The product which is the subject of this mdr has not been received for evaluation.Field correction z-2445-2023 was initiated due to premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case, the crossbar also breaks, and the rollator can possibly collapse causing injury to user.If additional information is received a follow up will be filed.

Event Description

The seat broke in the middle on a 2-year-old gloss 600 rollator.There were no injuries.

• Brand Name: DOLOMITE GLOSS 600
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE SWEDEN; 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: 18504267
• MDR Text Key: 333384152
• Report Number: 9615290-2024-00002
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2024

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: DOLOMITE GLOSS 600
• Device Catalogue Number: DOLOMITE GLOSS 600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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