MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for PALODENT V3 SYSTEM FORCEP REFILL 659810V manufactured by Dentsply Llc.
[140174039]
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.
Patient Sequence No: 1, Text Type: N, H10
[140174040]
In this event it was reported that a pair of palodent v3 forceps broke during use; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2019-00003 |
| MDR Report Key | 8372562 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-07-11 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2015-03-31 |
| Date Added to Maude | 2019-02-26 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | DENTSPLY LLC |
| Manufacturer Street | 38 WEST CLARKE AVENUE |
| 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 | 0 |
| Brand Name | PALODENT V3 SYSTEM FORCEP REFILL |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2019-02-26 |
| Catalog Number | 659810V |
| Lot Number | A0315 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 38 WEST CLARKE AVENUE MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |