ORTHODONTIC BRACES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-12 for ORTHODONTIC BRACES manufactured by Unk.

Event Text Entries

[102366291] I got my braces on (b)(6) 2012. My stupid dentist did not explain me the proper course of treatment and just told me that it would last for 18 months or so. Within 4 months, after getting the first wire into my mouth i started experiencing asthma and wheezing, cough could and other upper respiratory infections. Similarly i used to feel heaviness in my head, fatigue, muscle and joint pains. I visited chest specialist, orthopedist to explain my condition when i was (b)(6). But all the test reports came clear. Later i found that i was allergic to nickel chromium inside the steel wire of my braces. I was allergic to rubber hand / latex and the plastic used in the retainers which are later used in retention. Phase, initially the treatment of my crooked teeth as per my stupid dentist had to last only 18 months but that "profanity" took 2 yrs, 2 months to complete. He was also completely unaware of the side effects and allergies. I had completed treatment taking medications for asthma and skin allergies. Also sometimes needed hospitalization where i missed my several campus placements during my graduation. Orthodontic treatment do not suit everyone. Performed a huge number of tests for a number of materials used by the dentists before putting anything inside your mouth.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075837
• MDR Report Key: 7334373
• Date Received: 2018-03-12
• Date of Report: 2018-03-09
• Date of Event: 2018-03-09
• Date Added to Maude: 2018-03-13
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ORTHODONTIC BRACES
• Generic Name: IMPLANT, ENDOSSEOUS, ORTHODONTIC
• Product Code: OAT
• Date Received: 2018-03-12
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2018-03-12