MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS FILTEK SUPREME XTE UNIVERSAL RESTORATIVE; MATERIAL, TOOTH SHADE, RESIN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactic Shock (1703); Shock (2072)

Event Date 01/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2013, 3m espe was informed about an adverse effect that occurred after the use of 3m espe filtek supreme xte universal restorative.After the pt left the doctor's office on (b)(6) 2013, she suffered from rapid heartbeat, rash on the face, and a sensation of cold and trembling.One day later the husband of the pt reported to the dental office that she went into an anaphylactic shock and was treated in a hospital.As of (b)(6) 2013, the pt was still in hospital.No further follow-up information is currently available.

Manufacturer Narrative

The product wasn't returned to 3m espe and the lot number is not known.Therefore, no further analysis on the product or retain sample could be done.As of this report, it remains unk what caused the pt's symptoms.In addition to the reported 3m espe product, other dental materials from other manufacturers were used in the treatment.The dental office prepared a sample for allergy testing but this wasn't collected yet.This product has been assessed for biocompatibility and has been found to be safe for its intended use.3m espe will submit a follow-up report if any new information becomes available.

• Brand Name: FILTEK SUPREME XTE UNIVERSAL RESTORATIVE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; st. paul MN
• Manufacturer Contact: angie draper ; 3m center bldg 275-2w-08; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 3670210
• MDR Text Key: 4340365
• Report Number: 3005174370-2014-00004
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083610
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR