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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY LLC PALODENT V3 SYSTEM FORCEP REFILL INSTRUMENTS, DENTAL HAND

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DENTSPLY LLC PALODENT V3 SYSTEM FORCEP REFILL INSTRUMENTS, DENTAL HAND Back to Search Results
Catalog Number 659810V
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 has not been returned 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 v3 forceps broke during use; no injury resulted.
 
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Brand NamePALODENT V3 SYSTEM FORCEP REFILL
Type of DeviceINSTRUMENTS, DENTAL HAND
Manufacturer (Section D)
DENTSPLY LLC
38 west clarke avenue
milford DE 19963
Manufacturer (Section G)
DENTSPLY LLC
38 west clarke avenue
milford DE 19963
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key8372562
MDR Text Key140174039
Report Number2515379-2019-00003
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number659810V
Device Lot NumberA0315
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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