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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT PLUS FORCEPS; DENTAL HAND INSTRUMENT
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DENTSPLY CAULK PALODENT PLUS FORCEPS; DENTAL HAND INSTRUMENT Back to Search Results
Catalog Number 659810
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
In this event, it was reported that two pairs of palodent plus forceps broke at the tip while in the sterilizer; no pts were involved.
 
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.This report is for the second device.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
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Brand Name
PALODENT PLUS FORCEPS
Type of Device
DENTAL HAND INSTRUMENT
Manufacturer (Section D)
DENTSPLY CAULK
milford DE
Manufacturer Contact
helen lewis
221 w philadelphia st
ste 60
york, PA 17401
7178457511
MDR Report Key4623695
MDR Text Key5765472
Report Number2515379-2015-00021
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 02/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number659810
Device Lot NumberD1112
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2015
Initial Date FDA Received03/18/2015
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 Unknown
Patient Sequence Number1
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