MAUDE Adverse Event Report: INVAMEX MANUFACTURING DOLOMITE MAXI ROLLATOR 650 7331492560417; WALKER, MECHANICAL

Model Number NA:12120-37-23

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Concussion (2192)

Event Date 01/27/2021

Event Type  Injury  

Event Description

The user was sitting on his dolomite maxi 650 rollator when a rear wheel bracket (as sitting) snapped causing him to fall backwards & hit his head on a boat battery that was on the floor of his garage.The user was taken to the hospital where he was initially diagnosed with neck trauma, neck pain, back pain and headache resulting from the fall.He was later diagnosed with "post-concussion syndrome, myofascial pain syndrome, muscular and post concussion headaches, neck pain/cervical strain/sprain, bilateral lumbosacral strain/sprain, myofascial pain, bilateral thoracic strain/sprain/myofascial pain".

Manufacturer Narrative

The dolomite maxi 650 rollator was provided to the user by the va in 2018.Invacare has not yet had access to the device and is unable to determine the cause of the alleged malfunction with the available information.A follow up will be filed if new information is obtained.

• Brand Name: DOLOMITE MAXI ROLLATOR 650 7331492560417
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 16270496
• MDR Text Key: 308442290
• Report Number: 9616091-2023-00001
• 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
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:12120-37-23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 136 KG