PROPEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-11 for PROPEL manufactured by Propel Orthodontics.

Event Text Entries

[5506075] My gums were thoroughly numb, and i felt no mouth pain whatsoever. However, i had excruciating, shooting headache pain in the right occipital area of my head as my doctor began screwing in the device. It felt as if she was screwing each appliance into my brain. The pain worsened with each screw, and the pain spread across both sides and behind my eyes. After the install, while my gums and jaw was pain free, i was in tears, hyperventilating, and feeling like i was about to throw up from the pain. It took 45 mins to recover enough to leave the office. Frankly, this was on par with my worst labor pain! I am typically very tough and have no problem with procedures. The doctor said she had never heard about this happening, and couldn't think of a viable reason for the headache pain. This was about 36 hours ago, and despite taking (b)(6), i am still suffering from headache pain. My gums are still sore, but nothing significant. I was contacted by device rep and he said no effects like this reported. I want to make sure there is a record.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040781
• MDR Report Key: 4528366
• Date Received: 2015-02-11
• Date of Report: 2015-02-11
• Date of Event: 2015-02-10
• Date Added to Maude: 2015-02-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROPEL
• Generic Name: INSTRUMENT
• Product Code: EKD
• Date Received: 2015-02-11
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROPEL ORTHODONTICS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-02-11