MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for PALODENT V3 FORCEPS 659810V manufactured by Dentsply Caulk.
[83134712]
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 retained-product testing and/or dhr review are planned. The results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[83134713]
In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[118447911]
Multiple unsuccessful attempts were made to obtain the device for evaluation. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2017-00013 |
| MDR Report Key | 6803928 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-10-27 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-08-18 |
| 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 | 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 | 0 |
| Brand Name | PALODENT V3 FORCEPS |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2017-08-18 |
| Model Number | NA |
| Catalog Number | 659810V |
| Lot Number | A0416 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-18 |