• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT V3 FORCEPS INSTRUMENTS, DENTAL HAND

  • 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 CAULK PALODENT V3 FORCEPS INSTRUMENTS, DENTAL HAND Back to Search Results
Catalog Number 659810V
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device was not returned for evaluation. However, the lot number was provided and retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
 
Event Description
In this event it was reported that a pair of palodent v3 forceps broke at the tip; no injury resulted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePALODENT V3 FORCEPS
Type of DeviceINSTRUMENTS, DENTAL HAND
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
Manufacturer (Section G)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key8641755
MDR Text Key146262957
Report Number2515379-2019-00008
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number659810V
Device Lot NumberA1117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
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
Type of Device Usage Unkown

-
-