MAUDE Adverse Event Report: DOLOMITE SYMPHONY 600; WALKER, MECHANICAL

Model Number SYMPHONY 600

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/24/2023

Event Type  Injury  

Event Description

When the consumer was using the symphony rollator, the left front fork broke off.The user was hospitalized, but it is unknown what injuries they sustained.It was noted the consumer often travels by special transport services/taxis, involving repeated loading and unloading which possibly damaged the fork.No further details were received about the incident.

Manufacturer Narrative

On november 01, 2023, invacare was made aware of an event that occurred in sweden involving a dolomite symphony rollator.Invacare is filing this medwatch in an abundance of caution due to the dolomite symphony rollator was also sold in the u.S.This device was manufactured at invacare rea ab in sweden.It is unclear whether a defect, physical damage or use error contributed to the incident.Further information, and the return of the rollator has been requested, but not yet received.The dolomite futura/dolomite symphony rollator user manual (1543649-d) recommends to ensure performance and safety, to inspect the product regularly which includes the wheels¿ tightness, wear and damage.If additional information is received a follow-up will be filed.

• Brand Name: SYMPHONY 600
• 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; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18246549
• MDR Text Key: 329485973
• Report Number: 9615290-2023-00004
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2023

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 Model Number: SYMPHONY 600
• Device Catalogue Number: SYMPHONY 600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization