MAUDE Adverse Event Report: LATEX BANDS; BAND, ELASTIC, ORTHODONTIC

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 12/01/2023

Event Type  Injury  

Event Description

Developed latex allergy after using latex bands in mouth for orthodontics.Skin rash for 4 months ongoing since (b)(6) 2023.On (b)(6) 2023 required visit to urgent care and course of oral corticosteroid prescribed.Unable to determine which products and foods may cause allergic reaction due to latex allergy.Continue need for zyrtec daily, benadryl two or three times per day, kenalog cream.

• Brand Name: LATEX BANDS
• Type of Device: BAND, ELASTIC, ORTHODONTIC
• MDR Report Key: 18400336
• MDR Text Key: 331531743
• Report Number: MW5149597
• Device Sequence Number: 1
• Product Code: ECI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/21/2023

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2023
• Patient Sequence Number: 1
• Treatment: BENADRYL; FAMOTIDINE; KENALOG CREAM; VITAMIN D3; ZYRTEC
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian