MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING 1, LLC D-LISH DESSERT TRIO, ASSORTED PASTE; PROPHY PASTE

Catalog Number 295453

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

This was reported to the dentist and then young 6 months after the allergic reaction occured.Dental floss was the only other product used during visit however it is not known if latex was present.Dentist has historically used this product with no other reported reactions; furthermore young has not received any other reported reactions from this product.It was stated the allergic reaction lasted for 4 months and antibiotics was used to treat, however it is not known which antibiotic was used.This product is an assorted pack of 3 flavors and it is not known which flavor was used on the patient.No lot number was provided preventing the review of the device history record.

Event Description

Patient came in for regular appointment and notified dentist that after their last appointment the patient had an allergic reaction to the prophy paste used, d-lish dessert trio, which consisted of lips swelling and irritated skin in mouth.Lot number was not able to be provided nor was the specific flavor of paste from the assorted pack.Patient stated she went to the doctor who prescribed antibiotics and the allergic reaction lasted for 4 months.It is not known what antibiotic was prescribed.Patient's only known allergy is to latex.

• Brand Name: D-LISH DESSERT TRIO, ASSORTED PASTE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING 1, LLC; 13705 shoreline ct. e; earth city MO 63045
• Manufacturer Contact: jose espino ; 13705 shoreline ct. e; earth city, MO 63045 ; 3143440010
• MDR Report Key: 16691481
• MDR Text Key: 312800100
• Report Number: 1941138-2023-00002
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 295453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female