MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-29 for PALODENT 659500 manufactured by Dentsply Caulk.
[684695]
Doctor reported a malfunction of ring placement forceps caused ring to fall into patient's mouth. Patient did not swallow ring and there is no report of injury.
Patient Sequence No: 1, Text Type: D, B5
[7878468]
While there was no injury reported in this case, a previous report was filed pertaining to irreversible damage to a tooth requiring intervention, thereby establishing that the malfunction is likely to cause or contribute to a death or serious injury. Therefore, this event is reportable. Further testing will be performed on the returned device and results will be reported as they become available. Results of the dhr review are attached.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2004-00480 |
| MDR Report Key | 910310 |
| Report Source | 05 |
| Date Received | 2004-10-29 |
| Date of Report | 2004-09-30 |
| Date of Event | 2004-09-30 |
| Date Mfgr Received | 2004-09-30 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2007-09-12 |
| 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 | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARKE 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 |
| Generic Name | SECTIONAL MATRIX SYSTEM, PLACEMENT FORCEPS |
| Product Code | EJG |
| Date Received | 2004-10-29 |
| Returned To Mfg | 2004-10-24 |
| Model Number | NA |
| Catalog Number | 659500 |
| Lot Number | 040126 (INVALID) |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 884068 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | * MILFORD DE * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-29 |