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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 Pain (1994)
Event Type  malfunction  
Event Description
In this event it was reported that a pair of palodent plus forceps broke during use and hit a pt's lip, causing pain; however no serious 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 FORCEPS
Type of Device
DENTAL HAND INSTRUMENT
Manufacturer (Section D)
DENTSPLY CAULK
milford DE
Manufacturer Contact
helen lewis
susquehanna commerce ctr w
221 w philadelphia st, ste 60
york, PA 17401
7178457411
MDR Report Key3906929
MDR Text Key4514278
Report Number2515379-2014-00012
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeGM
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 02/11/2014
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 NumberD1112
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2014
Initial Date FDA Received03/06/2014
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 Reuse
Patient Sequence Number1
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