FDA Adverse Event
Malfunction
Summary report: N
PALODENT PLUS FORCEPS
MDR report key: 4905417
·
Received July 7, 2015
Report
- Report Number
- 2515379-2015-00046
- Event Type
- Malfunction
- Date Received
- July 7, 2015
- Report Date
- June 7, 2015
- Manufacturer
- DENTSPLY CAULK
- Product Code
- DZN
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME. THE DEVICE WAS NOT RETURNED 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND A DHR REVIEW IS PLANNED. THE 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. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION. ADDITIONAL INFORMATION IS BEING REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440095 | PALODENT PLUS FORCEPS | DENTAL HAND INSTRUMETN | DZN | DENTSPLY CAULK | D0212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |