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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 Material Twisted/Bent (2981)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
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. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a pair of palodent plus forceps were bent at the tip. The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
The vendor found that excessive pressure caused the deformity in the forceps. Multiple unsuccessful attempts were made to obtain the patient outcome.
 
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Brand NamePALODENT PLUS FORCEPS
Type of DeviceINSTRUMENTS, DENTAL HAND
Manufacturer (Section D)
DENTSPLY CAULK
38 w. clark ave.
milford DE 19963
MDR Report Key7721290
MDR Text Key115066261
Report Number2515379-2018-00007
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number659810
Device Lot Number106067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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