MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-29 for PALODENT BITINE RING UNK manufactured by Dentsply Caulk.
[318827]
The doctor reported that the bitine ring sprang off of a tooth being restored and fractured an adjacent tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2003-00177 |
| MDR Report Key | 492209 |
| Report Source | 05 |
| Date Received | 2003-10-29 |
| Date of Report | 2003-09-30 |
| Date Mfgr Received | 2003-09-30 |
| Date Added to Maude | 2003-10-30 |
| 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 | 0 |
| 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 | 570 WEST COLLEGE AVENUE |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 WEST CLARKE AVENUE |
| Manufacturer City | MILFORD DE 19963035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 0359 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALODENT BITINE RING |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | EJG |
| Date Received | 2003-10-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480909 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. MILFORD DE 199630359 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-29 |