MAUDE Adverse Event Report: MY01 INC. MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR; MY01 DEVICE

Model Number MY01-0001

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

Patient Problem Loss of consciousness (2418)

Event Date 09/17/2021

Event Type  Injury  

Event Description

This was reported by the my01 client success consultant who was present during the incident: my01 continuous compartmental pressure monitor was being used on a patient to monitor their compartment pressure.The physician inserted the device with ease, without the use of a local anesthetic (physician'schoice).Some time after insertion, the patient fell unconscious for a few seconds.The physician and nursing staff were available andimmediately cared for the patient.The patient woke up within seconds and was examined, the health-care team deemed them to be in goodhealth.The devices were subsequently removed and disposed at thefacility.During their interaction with the physician, the patient mentioned thatthey were uncomfortable around needles.

• Brand Name: MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR
• Type of Device: MY01 DEVICE
• Manufacturer (Section D): MY01 INC.; 400 boul de maisonneuve ouest,; suite 700; montreal, quebec H3A 1 L4; CA H3A 1L4
• MDR Report Key: 12708197
• MDR Text Key: 284459065
• Report Number: 3017398927-2021-00001
• Device Sequence Number: 1
• Product Code: LXC
• Combination Product (y/n): N
• PMA/PMN Number: K210525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/28/2021

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: Health Professional
• Device Model Number: MY01-0001
• Device Lot Number: 9449844
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR