3M FILTEK P60 POSTERIOR RESTORATIVE UNK 4720A3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-08 for 3M FILTEK P60 POSTERIOR RESTORATIVE UNK 4720A3 manufactured by 3m Espe Dental Products.

Event Text Entries

[668487] Device 1. 3m espe was recently notified of an event that occurred approximately 1-1/2 years ago. On the day of the event, a pediatric patient visited the reporting dentist for treatment that involved two 3m espe products, p60 (update full tradename) and clincpro selant (update full tradename). The patient left the office and later the same day was seen by a pediatric dentist or pediatric physician (details on the type of professional are not available to 3m espe). It is reported that following a shot of some type (details on type of shot are not available to 3m espe), the patient stopped breathing and when into a coma, where he has remained for the last 1-1/2 years. Additional details on this situation are not available to 3m espe, because of potential and pending litigation, the dentist making the report to 3m espe was not willing to provide any additional information for use in the investigation of the event.
Patient Sequence No: 1, Text Type: D, B5


[8127914] Device not returned, therefore, no evaluation was conducted. Both 3m espe products reported to have been used in treatment of this patient have very favorable clinical use histories without any other allegation of this type. Based on the biocompatibility assessments of these products along with their favorable use history, this type of adverse health effect is not expected from the intended use of the products.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2110898-2007-00009
MDR Report Key892667
Report Source05
Date Received2007-08-08
Date of Report2007-08-07
Date of Event2006-02-16
Date Mfgr Received2006-07-23
Date Added to Maude2007-08-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCAROLYN KRAMPE
Manufacturer Street3M CENTER, BLDG. 260-2A-17
Manufacturer CityST. PAUL MN 551441000
Manufacturer CountryUS
Manufacturer Postal551441000
Manufacturer Phone6517361148
Manufacturer G13M ESPE DENTAL PRODUCTS DIVISION
Manufacturer Street2111 MCGAW AVENUE
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M FILTEK P60 POSTERIOR RESTORATIVE
Generic NameRESIN BASED RESTORATIVE MATERIAL
Product CodeNSM
Date Received2007-08-08
Model NumberUNK
Catalog Number4720A3
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key873910
Manufacturer3M ESPE DENTAL PRODUCTS
Manufacturer Address2111 MCGAW AVENUE IRVINE CA 92614 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-08-08

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