MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for PALODENT V3 FORCEPS 659810V manufactured by Dentsply Caulk.
[63846735]
There has been a previous report received where this malfunction with a similar device 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.
Patient Sequence No: 1, Text Type: N, H10
[63846736]
In this event it was reported that a pair of palodent v3 forceps broke at the tip. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
[65821612]
The right tip has broken off. Other tip still looks ok. No other signs of bending or cracking across the forceps. A scar has been issued to the original manufacturer to correct this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2016-00031 |
| MDR Report Key | 6215638 |
| Date Received | 2016-12-30 |
| Date of Report | 2017-01-25 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARK AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALODENT V3 FORCEPS |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2016-12-30 |
| Returned To Mfg | 2016-12-14 |
| Model Number | NA |
| Catalog Number | 659810V |
| Lot Number | A0614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 W. CLARK AVE. MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-30 |