MAUDE Adverse Event Report: COLGATE-PALMOLIVE COLGATE SENSITIVE PRORELIEF UNSPECIFIED TOOTHPASTE

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Swelling (2091); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Initial info was received on (b)(6) 2014 from a dental hygienist.This female consumer used colgate sensitive prorelief unspecified toothpaste and experienced an anaphylactic reaction, lip swelling and swelling of the tongue.The consumer was given a tube of the paste by her dental office and she began using the toothpaste on an unk date (dose and frequency unk).Subsequently, on an unspecified date she began to experience the events.At the time of this report, action taken with the toothpaste and the outcomes of the events were unk.This case is referenced as (b)(4).

• Brand Name: COLGATE SENSITIVE PRORELIEF UNSPECIFIED TOOTHPASTE
• Type of Device: TOOTHPASTE
• Manufacturer (Section D): COLGATE-PALMOLIVE; 909 river rd
• Manufacturer Contact: leonard humel, pharmd ; 909 river rd; piscataway, NJ 08854 ; 7328787930
• MDR Report Key: 4561970
• MDR Text Key: 5474288
• Report Number: 9613415-2014-00001
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial
• Report Date: 12/11/2014

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
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/18/2014
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other