MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY ENAMEL PRO PROPHY PASTE; PROPHYLAXIS PASTE

Catalog Number 9046073

Device Problems Inadequate Instructions for Non-Healthcare Professional (2956); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vomiting (2144)

Event Date 11/01/2022

Event Type  Injury  

Event Description

4 year old son found a sample of enamel pro prophy paste and ate one.He vomited.It was advised by premier to the mother to take her son to the emergency room.Enamel pro prophy paste's msds sheet was provided.

• Brand Name: ENAMEL PRO PROPHY PASTE
• Type of Device: PROPHYLAXIS PASTE
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): MEDICAL PRODUCTS LABORATORIES, INC.; 9990 global rd.; philadelphia PA 19115
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 2156769090
• MDR Report Key: 15807736
• MDR Text Key: 303758225
• Report Number: 2511556-2022-00004
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 9046073
• Date Manufacturer Received: 11/01/2022
• 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): Hospitalization
• Patient Age: 4 YR
• Patient Sex: Male