FDA Adverse Event
Malfunction
Summary report: N
PALODENT PLUS FORCEPS
MDR report key: 5032667
·
Received August 26, 2015
Report
- Report Number
- 2515379-2015-00054
- Event Type
- Malfunction
- Date Received
- August 26, 2015
- Report Date
- July 31, 2015
- Manufacturer
- DENTSPLY CAULK
- Product Code
- DZN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.
Additional Manufacturer Narrative · 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.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT A PAIR OF PALODENT PLUS FORCEPS BROKE AT THE TIP; NO INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566493 | PALODENT PLUS FORCEPS | INSTRUMENTS, DENTAL HAND | DZN | DENTSPLY CAULK | D0912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |