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 VDW GMBH EDDY IRRIGATION TIP; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
  • 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 VDW GMBH EDDY IRRIGATION TIP; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING Back to Search Results
Catalog Number V041441000000
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event a customer reported that two eddy irrigation tips broke during treatment of different patients.This report is for the first of two reported events.The outcome of the event is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EDDY IRRIGATION TIP
Type of Device
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Manufacturer (Section D)
DENTSPLY VDW GMBH
bayerwaldstrasse 15
munich, 81737
GM  81737
MDR Report Key10881532
MDR Text Key217946491
Report Number9611053-2020-00355
Device Sequence Number1
Product Code EIC
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,Followup
Report Date 01/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberV041441000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-