MAUDE Adverse Event Report: KERR CORPORATION SONICFILL 3 COMPOSITE; TOOTH SHADE RESIN MATERIAL

Catalog Number 36712

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

A complainant alleged patient experienced swollen lips and gums within twelve hours of dentists visit.It was reported that patient is allergic to expoxy resins, which is not present in sonicfill.There were other products used during the procedure which included prime & bond nt/microprime.The patient had to go to the er and was placed on (b)(6) and oral steroids.It was reported that patient was asymptomatic but still on steroids.No patient information was provided in regards to age, ethnicity, and race.The product was not returned, therefore no evaluation can be conducted.

Event Description

A complainant alleged patient experienced swollen lips and gums within twelve hours of dentists visit.

• Brand Name: SONICFILL 3 COMPOSITE
• Type of Device: TOOTH SHADE RESIN MATERIAL
• Manufacturer (Section D): KERR CORPORATION; 1717 w.collins avenue; orange CA 92867
• Manufacturer (Section G): KAVO KERR; 1717 w collins avenue; orange CA 92867
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, CA 92867
• MDR Report Key: 9211527
• MDR Text Key: 162998858
• Report Number: 2024312-2019-00002
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KO91023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 36712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other