MAUDE Adverse Event Report: MOTEK MEDICAL B.V. C-MILL; POWERED TREATMILL

Model Number VR+

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/15/2021

Event Type  Injury  

Event Description

An employee broke her finger while attempting to adjust the handrails.It was the operator/ therapist, not the patient, who was injured.

• Brand Name: C-MILL
• Type of Device: POWERED TREATMILL
• Manufacturer (Section D): MOTEK MEDICAL B.V.; vleugelboot 14; houten noord-brabant, 3991 CL; NL 3991 CL
• Manufacturer (Section G): MOTEK MEDICAL B.V.; vleugelboot 14; houten noord-brabant, 3991 CL; NL 3991 CL
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 13319044
• MDR Text Key: 284283625
• Report Number: 3006750942-2021-00001
• Device Sequence Number: 1
• Product Code: IOL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VR+
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR