MAUDE Adverse Event Report: E.C. MOORE COMPANY INC. SPARKLE FREE PROPHY PASTE

Model Number UPSMF

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

Patient Problems Vomiting (2144); Reaction (2414)

Event Date 11/23/2015

Event Type  Injury  

Event Description

The patient became sick after having a dental procedure that used sparkle free prophy paste.No medical treatment was sought.(b)(4) is not the manufacturer of sparkle free prophy pase, it is just the distributor.This complaint will continue to be monitored in the (b)(4) complaint system.

• Brand Name: SPARKLE FREE PROPHY PASTE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): E.C. MOORE COMPANY INC.; 13325 leonard st.; dearborn MI 48126
• MDR Report Key: 5320090
• MDR Text Key: 34164177
• Report Number: 2433773-2015-00004
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: UPSMF
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Report to Manufacturer: 12/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 MO