MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for PALODENT PLUS FORCEPS 659810 manufactured by Dentsply Caulk.
[63074519]
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 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
[63074520]
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
[65837610]
Right tip has broken off. Fracture surface shows signs of corrosion well across the surface which indicates there was likely a crack in the bent area for some time before the breakage. The left tip is still intact but it also has a crack in the bend which would also have failed soon. Incorrect manufacture of the tip area is the most likely cause of the initial cracking which ultimately leads to the breakage. A scar has been issued to the original manufacturer to correct this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2016-00029 |
| MDR Report Key | 6182909 |
| Date Received | 2016-12-16 |
| Date of Report | 2017-01-25 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-12-16 |
| 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 | 3 |
| Brand Name | PALODENT PLUS FORCEPS |
| Generic Name | INSTRUMENTS, DENTAL HAND |
| Product Code | DZN |
| Date Received | 2016-12-16 |
| Returned To Mfg | 2016-12-05 |
| Model Number | NA |
| Catalog Number | 659810 |
| Lot Number | A1213 |
| 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 | 2016-12-16 |