FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DENTSPLY MAILLEFER MAILLEFER THERMAFIL OBTURATOR GUTTA PERCHA OBTURATOR   back to search results
Model Number ISO 30
Event Date 03/12/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The dr reported the pt experienced a skin rash after a dental procedure with thermafil. The skin rash did improve after being treated with xusal. However, the pt experienced two asthma attacks upon termination of the xusal treatment.

 
Manufacturer Narrative

Allergic reactions to components of dental materials, colorants and flavorings are known and reported, and would be considered an mdr reportable event. Medical consequences are dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Section d 8. No section d 9. Na.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameMAILLEFER THERMAFIL OBTURATOR
Type of DeviceGUTTA PERCHA OBTURATOR
Baseline Brand NameMAILLEFER THERMAFIL OBTURATOR
Baseline Generic NameGUTTA PERCHA OBTURATOR
Baseline Catalogue NumberA0166
Baseline Model NumberISO 30
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DENTSPLY MAILLEFER
ballaigues
SWITZERLAND CH-1338
Manufacturer (Section D)
DENTSPLY MAILLEFER
ballaigues
SWITZERLAND CH-1338
Manufacturer (Section G)
DENTSPLY TULSA
608 rolling hills dr
johnson city TN 37604
Manufacturer Contact
patricia kihn
221 w. phila. st., ste. 60
susquehanna commerce ctr w.
york , PA 17404
(717) 845 -7511
Device Event Key511178
MDR Report Key522048
Event Key495419
Report Number2320721-2004-00215
Device Sequence Number1
Product CodeEKM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation DENTIST
Type of Report Initial
Report Date 03/25/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberISO 30
Device Catalogue NumberA0166
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2004
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH