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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
In this event it was reported that a pair of palodent plus forceps would drop the rings without releasing them; 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 a ring that was unintentionally released from a pair of forceps 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.
 
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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
york, PA 17401
7178457511
MDR Report Key4234842
MDR Text Key4972346
Report Number2515379-2014-00055
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeSW
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 08/20/2014
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2014
Initial Date FDA Received08/28/2014
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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