MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-24 for PARAPOST FIBER LUX INTRO KIT PF170 manufactured by Coltene Whaledent Inc..
| Report Number | 2416455-2019-00003 |
| MDR Report Key | 9109415 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-24 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-08-27 |
| Device Manufacturer Date | 2018-03-16 |
| Date Added to Maude | 2019-09-24 |
| 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 | MS. TRICIA CREGGER |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168904 |
| Manufacturer G1 | COLTENE WHALEDENT INC. |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARAPOST FIBER LUX INTRO KIT |
| Generic Name | DENTAL KIT (DRILLS, POSTS) |
| Product Code | ELR |
| Date Received | 2019-09-24 |
| Model Number | PF170 |
| Catalog Number | PF170 |
| Lot Number | I42379 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE WHALEDENT INC. |
| Manufacturer Address | 235 ASCOT PARKWAY CUYAHOGA FALLS OH 44223 US 44223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-24 |