Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY DETREY GMBH IRM CEMENT; CEMENT, DENTAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTSPLY DETREY GMBH IRM CEMENT; CEMENT, DENTAL Back to Search Results
Catalog Number 606.61.500
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.In case of allergic reactions no tests in qc is possible.
 
Event Description
It was reported that a patient experienced symptoms such as headache, severe migraines, dizziness, and irregular blood pressure, after the use of irm cement.The dentist removed the irm plaster, and symptoms disappeared on the same day.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IRM CEMENT
Type of Device
CEMENT, DENTAL
Manufacturer (Section D)
DENTSPLY DETREY GMBH
detrey strasse 1
konstanz, 78467
GM  78467
MDR Report Key10179378
MDR Text Key198165706
Report Number8010638-2020-00005
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number606.61.500
Device Lot Number1808000794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
-
-