MAUDE Adverse Event Report: DOLOMITE DOLOMITE MAXI 550 XL; MECHANICAL WALKER (WHEELS & NO WHEELS)

Model Number EU:12122-37-23

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fracture, Arm (2351)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), invacare is filing this report because the device is also marketed and sold in the u.S.Invacare europe received pictures confirming right front fork was detached from the rollator with a broken bearing and the left front fork is still tightly attached but tilted slightly to the side.Invacare europe has requested the device be returned for investigation, but as of 9/18/2018 has not received the device.Based on the available information, the underlying cause of the issue could not be confirmed.Should additional information become available, a supplemental record will be filed.

Event Description

While using the rollator, the right front fork assembly came loose, detaching from the device.When the fork assembly came off, the user fell breaking their arm.

Manufacturer Narrative

The rollator was returned to (b)(4), an evaluation was completed.It can be confirmed that one front fork fell off the rollator due to a broken ball bearing at the top of the fork.The ball bearing breakage is consistent with overload resulting in disassembly of the fork from the frame.The investigation of the broken ball bearing has shown that there are some small dents at the edges of the running paths, both at the inner and the outer ring of the ball bearing.This indicates that the ball bearing has been exposed to extreme loads.The most probable cause of the incident is that the front fork hit an obstacle while under an extreme load.

Event Description

While using the rollator, the right front fork assembly came loose, detaching from the device.When the fork assembly came off, the user fell breaking their arm.

• Brand Name: DOLOMITE MAXI 550 XL
• Type of Device: MECHANICAL WALKER (WHEELS & NO WHEELS)
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio
• Manufacturer (Section G): DOLOMITE; box 200; vaxjovagen 303; dio
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44036 ; 8003336900
• MDR Report Key: 7885839
• MDR Text Key: 120572770
• Report Number: 9615290-2018-00006
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EU:12122-37-23
• Device Catalogue Number: 12122-37-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 102