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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 11/13/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, it was reported to 3m (b)(4) that an allergic reaction occurred in a (b)(6) year-old (b)(6) patient after a dental treatment involving 3m espe filtek supreme ultra universal restorative.Some hours after the treatment, the patient began to experience swelling of the face and sought medical attention at a hospital; she was admitted for further monitoring.It is not known what treatment, if any, she was provided.

• Brand Name: 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 6196489
• MDR Text Key: 63059587
• Report Number: 3005174370-2016-00155
• 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: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service Personnel
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR