MAUDE Adverse Event Report: KERR CORPORATION TEMPSPAN TRANSPARENT TEMPORARY CEMENT; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number N69CB

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Irritation (1941); Reaction (2414)

Event Type  Injury  

Event Description

A doctor's office alleged that the tempspan transparent temporary cement the product was too clear and that the product had not been completely removed from the margins during patient procedures.Two (2) patients had experienced a reaction with symptoms of bleeding and irritated gums which required a prescription mouthwash to alleviate symptoms due to insufficient removal of the excess cement.This is the first of two (2) reports.

Manufacturer Narrative

Although the office identified two (2) different lots associated with the gum irritation, the office could not verify which lot had been used on the patient; therefore, no lot numbers were identified in this report.The lots involved in the alleged incident include lot numbers 5169229 and 4785393.The patient returned to the office and the excess cement was removed.The doctor also prescribed peridex for treatment of the symptoms.The symptoms had fully subsided after the temporaries were removed and the permanent crowns were placed.To date, the patient has fully recovered and is doing fine.The products involved in the alleged incidents were not returned; therefore, a retained sample from both lots was evaluated, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process for either lot.In addition, no similar complaints were received with regard to these lots.The tempspan transparent directions for use include a contraindication which states: "uncured methacrylate resin may cause contact dermatitis and damage the pulp.Avoid contact with skin, eyes, and soft tissue".

• Brand Name: TEMPSPAN TRANSPARENT TEMPORARY CEMENT
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer (Section G): KERR CORPORATION; 1717 west collins avenue; orange CA 92867
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3994961
• MDR Text Key: 4819416
• Report Number: 2024312-2014-00529
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: N69CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• 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; Required Intervention
• Patient Age: 45 YR