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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT PLUS PLACEMENT FORCEPS; DENTAL HAND INSTRUMENT

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DENTSPLY CAULK PALODENT PLUS PLACEMENT FORCEPS; DENTAL HAND INSTRUMENT Back to Search Results
Catalog Number 659810
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2014
Event Type  malfunction  
Event Description
In this event it was reported that a pair of palodent plus forceps cracked at the tip; no injury resulted.
 
Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received in the past two years 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.
 
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Brand Name
PALODENT PLUS PLACEMENT FORCEPS
Type of Device
DENTAL HAND INSTRUMENT
Manufacturer (Section D)
DENTSPLY CAULK
milford DE
Manufacturer Contact
helen lewis
221 w. philadelphia st. ste .60
susquehanna commerce center w.
york, PA 17401
7178457511
MDR Report Key4172535
MDR Text Key21841992
Report Number2515379-2014-00059
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/22/2014
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 NumberD0312
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/05/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/22/2014
Initial Date FDA Received09/19/2014
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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