FDA.reportPublic FDA data

MAUDE MDR 6487285

MDR report key
6487285
Report number
2515379-2017-00006
Event key
0
Event type
3
Date received
2017-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. HELEN LEWIS
Address
221 W. PHILADELPHIA ST. SUITE 60W YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PALODENT PLUS FORCEPSINSTRUMENTS, DENTAL HANDDENTSPLY CAULKDZNNA659810A0315Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-120

Event Narratives#

N

Patient 1

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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

D

Patient 1

IN THIS EVENT IT WAS REPORTED THAT A PAIR OF PALODENT PLUS FORCEPS BROKE AT THE TIP AFTER CLEANING; NO PATIENT WAS INVOLVED.

N

Patient 1

FORCEPS HAVE A BROKEN (RIGHT) TIP. THEY ARE QUITE CONTAMINATED WITH DARK MARKS ESPECIALLY AROUND THE PIVOT. NO FURTHER EVIDENCE OF MISUSE (NO BENDS, NO SCRATCHES). ALTHOUGH OUT OF WARRANTY THE TIPS SHOULDN'T BREAK WITH NORMAL USE.