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

Model Number GLOSS 600

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This event in occurred 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 2022, and the serial number falls in the range of the field correction.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 collapse possibly causing injury to user.If additional information is received a follow up will be filed.

Event Description

The a 2.5 year-old dolomite gloss rollator has a broken seat.The end-user did not fall and was not injured.

• Brand Name: GLOSS 600
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE SWEDEN; box 200; vaxjovagen 303; dio ; SW
• Manufacturer (Section G): DOLOMITE SWEDEN; box 200; vaxjovagen 303; dio ; SW
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036
• MDR Report Key: 18504340
• MDR Text Key: 333393537
• Report Number: 9615290-2024-00003
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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 Operator: Lay User/Patient
• Device Model Number: GLOSS 600
• Device Catalogue Number: 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: 02/01/2022
• 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