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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.Evaluation confirmed the device is broken.
 
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 Name
PALODENT PLUS FORCEPS
Type of Device
INSTRUMENTS, 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
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key7685387
MDR Text Key114282047
Report Number2515379-2018-00006
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
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number659810
Device Lot NumberA0416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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