MAUDE Adverse Event Report: KERR CORPORATION PREMISE; TOOTH SHADE RESIN MATERIAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

No patient information was provided in regards to weight, ethnicity, and race.No lot number was provided therefore manufactured date cannot be provided.The product was not returned and no lot number was provided; therefore an evaluation was not conducted.

Event Description

A complainant alleged that the patient's gums got inflamed and had an allergic reaction including swelling.It was reported that the patient had four fillings done with premise.The dentist prescribed antibiotics, amoxicillin, cortizone and perioguard.Patient was also treated by a periodontist who prescribed hydrogen peroxide.

Manufacturer Narrative

Awareness date was corrected.

• Brand Name: PREMISE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): KERR CORPORATION; 1717 w collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 w collins avenue; orange CA 92867
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, CA 92867
• MDR Report Key: 7907945
• MDR Text Key: 121703873
• Report Number: 2024312-2018-00003
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR