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U.S. Department of Health and Human Services

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

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DENTSPLY CAULK PALODENT PLUS FORCEPS INSTRUMENTS, DENTAL HAND Back to Search Results
Catalog Number 659810
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 is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
 
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Brand NamePALODENT PLUS 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
7178494424
MDR Report Key9533713
MDR Text Key198552008
Report Number2515379-2019-00035
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number659810
Device Lot NumberD0213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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