MAUDE Adverse Event Report: KERR ITALIA S.R.L. TEMPBOND NE; TEMPORARY DENTAL CEMENT

Catalog Number 33685

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/03/2015

Event Type  Injury  

Event Description

A doctor's office had alleged that a patient had experienced an allergic reaction two (2) days after a dental procedure in which the tempbond ne and take 1 advanced tray, take 1 advanced wash, and take 1 advanced bite registration materials were utilized.

Manufacturer Narrative

The reaction initially began as an itchy rash on both hips, thighs, and legs.Two (2) days later, she developed a fever, coughing, and trouble breathing.The patient sought further medical attention at the er on (b)(6), 2015 for treatment and was administered an epipen, ventoline inhalations, and an injection of xolair.She was then admitted to the intensive care unit, and was administered solu-medrol, tavegyl and continued ventoline inhalations.She was also given a high dose of prednisolone for the rash for 10 days, and telfast tablets four (4) times daily.The tooth filling was removed on (b)(6) 2015, and it was reported that the rash dissipated.A steroid cream (elocon) was prescribed for use on the rash.A visual evaluation and blood tests were performed, and the patient was diagnosed with a pharmocological allergic reaction.The patient was in the hospital for a total of two (2) weeks.To date, the patient has recovered and is doing fine.It was reported that other dental products were also used during the procedure; however, it was not known which one may have caused the reaction.The patient is currently seeking further medical attention with an allergist to determine the cause of the incident.An update will be provided when new information becomes available.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted.

• Brand Name: TEMPBOND NE
• Type of Device: TEMPORARY DENTAL CEMENT
• Manufacturer (Section D): KERR ITALIA S.R.L.; via passanti 332; scafati (sa), I-84 018; IT I-84018
• Manufacturer (Section G): KERR ITALIA S.R.L.; via passanti 332; scafati (sa), I-84 018; IT I-84018
• Manufacturer Contact: kerri casino ; 1717 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 4811547
• MDR Text Key: 5891883
• Report Number: 8020994-2015-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K003658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/21/2015

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?: No
• Device Operator: Dentist
• Device Catalogue Number: 33685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/02/2015
• 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
• Treatment: TAKE 1 ADVANCED BITE REGISTRATION; TAKE 1 ADVANCED TRAY FAST SET; TAKE 1 ADVANCED LIGHT BODY WASH
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 95