MAUDE Adverse Event Report: SDS DE MEXICO U1L DAMON Q2 .022 STD TQ; BRACKET, METAL, ORTHODONTIC

Catalog Number 491-8861

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Patient had an allergic reaction to the orthodontic treatment (dq2 brackets).Patient experimented the following symptoms: nausea, headaches, tremors, allergies to proteins and sugars, sleeplessness, irritability, diarrhea, abdominal pain, aching joints, confusion, inability to focus and blurred vision.Due to the symptoms the patient experimented; it is considered as a serious injury.The injury was nickel toxic effects, so not directly connected to a device malfunction but rather to device composition.Orthodontic device installation started on (b)(6) 2019 and the symptoms started in late (b)(6).Patient was seeking medical attention with a pediatrician then was referred to a gi doctor.Initially the patient was diagnosed as celiac disease (on (b)(6) 2020) which was later determined to be a misdiagnosis as it could not explain all the symptoms, the test performed were celiac panel and upper gi.The patient was seen on an off over a 3-year period for blood work, mri, and additional testing to understand why the symptoms continued to get worse.Mother requested to remove the metal from patient's mouth (on (b)(6) 2022), the symptoms began to subsid e within days of removing the brackets and continued to subside until they were entirely gone in 4 months.The celiac symptoms stopped as soon as the braces were taken off.First notification was received under (b)(4) on (b)(6) 2022, was evaluated and determinated as not reportable due to not having enough information from dr and decided to closed the complaint.Additional information was received 04/28/23 and will be handle under (b)(4).

Event Description

Patient had an allergic reaction to the orthodontic treatment (dq2 brackets).Patient experimented the following symptoms: nausea, headaches, tremors, allergies to proteins and sugars, sleeplessness, irritability, diarrhea, abdominal pain, aching joints, confusion, inability to focus and blurred vision.Due to the symptoms the patient experimented; it is considered as a serious injury.The injury was nickel toxic effects, so not directly connected to a device malfunction but rather to device composition.Orthodontic device installation started in october 2019 and the symptoms started in late (b)(6).Patient was seeking medical attention with a pediatrician then was referred to a gi doctor.Initially the patient was diagnosed as celiac disease (on (b)(6) 2020) which was later determined to be a misdiagnosis as it could not explain all the symptoms, the test performed were celiac panel and upper gi.The patient was seen on an off over a 3-year period for blood work, mri, and additional testing to understand why the symptoms continued to get worse.Mother requested to remove the metal from patient's mouth (on (b)(6) 2022), the symptoms began to subsid e within days of removing the brackets and continued to subside until they were entirely gone in 4 months.The celiac symptoms stopped as soon as the braces were taken off.First notification was received under (b)(4) on (b)(6) 2022, was evaluated and determinated as not reportable due to not having enough information from dr and decided to closed the complaint.Additional information was received 04/28/23 and will be handle under (b)(4).

• Brand Name: U1L DAMON Q2 .022 STD TQ
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; cto. sur 31, nelson; mexicali, baja california 21395 ; MX 21395
• Manufacturer Contact: procoro herrera ; 200 s kraemer blvd; brea, CA 92821 ; 7148174396
• MDR Report Key: 16845721
• MDR Text Key: 314307574
• Report Number: 2016150-2023-00002
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 491-8861
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Male