MAUDE Adverse Event Report: DOLOMITE DOLOMITE MELODY M; WALKER, MECHANICAL

Model Number EU:12012-44-21HPL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

This event in occurred in finland involving a dolomite melody rollator.Invacare is filing this medwatch due to the dolomite melody rollator was also sold in the u.S by clarke healthcare.This device was manufactured at invacare rea ab in sweden in august 2019.No return was requested.According to the hospital technician, the brakes were working fine, and there was no malfunction of the device.The unintended user error caused or contributed to the incident.If additional information is received a follow-up will be filed.

Event Description

The customer was walking downhill, when the melody rollator started to move too fast for the patient.They lost their grip and fell on their left arm.Their left arm is now sore from the incident, especially the shoulder.The customer has taken strong painkillers and applied cold gel, which hasn¿t helped.They have not been to a doctor but are receiving massage and cold therapy.

• Brand Name: DOLOMITE MELODY M
• 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; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 14843293
• MDR Text Key: 295055110
• Report Number: 9615290-2022-00005
• 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: 05/30/2022

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: EU:12012-44-21HPL
• Device Catalogue Number: MELODY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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