MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING CO 1, LLC. D-LISH PROPHY PASTE WITH A D-LISH TASTE - GRAPE, FINE

Model Number 303220

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Reaction (2414)

Event Date 02/26/2016

Event Type  Injury  

Manufacturer Narrative

A dental student was using this product on a friend.There was no mention that this individual was performing this procedure under the supervision of a teacher.This product's directions for use state that it is to be administered professionally.Without the oversite of the medical professional it is hard to tell is there were any other factors that may have contributed to this adverse reaction.An allergen statement for the artificial grape flavoring used in this product was available, and states that the flavoring is free of the most common food allergens.Since the product was not returned for investigation (was used) and a lot number was not received, performing an analysis on this product is difficult.Therefore, the device history records for the past month were reviewed for any anomalies, none were found.

Event Description

A dental student received d-lish grape fine paste from her school.She used it to polish one of her friend's teeth.Her friend had an allergic reaction.Her friend's lips swelled.She is not aware of any allergies other than avocado.Medical attention was not required.She took benadryl and the side effects subsided.

• Brand Name: D-LISH PROPHY PASTE WITH A D-LISH TASTE - GRAPE, FINE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING CO 1, LLC.; 13705 shoreline court e.; earth city MO 63045
• Manufacturer (Section G): YOUNG DENTAL MANUFACTURING CO 1, LLC; 13705 shoreline court e.; earth city MO 63045
• Manufacturer Contact: sarah moore ; 13705 shoreline court e.; earth city, MO 63045 ; 3143440010
• MDR Report Key: 5486155
• MDR Text Key: 39888743
• Report Number: 1941138-2016-00009
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 303220
• Device Catalogue Number: 303220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2016
• 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