MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-08 for POGO ONE STEP DIAMOND MICRO POLISHER 662010 manufactured by Dentsply Caulk.
[309204]
The dentist reported cutting the pt's cheek with the polishing disc. The pt did not go to the er, but the dentist administered antibiotics and stitches to complete the procedure. The pt returned to the dentist's office for removal of the stitches and it was reported that the area was probably a little sore, but showed no signs of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2004-00182 |
| MDR Report Key | 519916 |
| Report Source | 05 |
| Date Received | 2004-04-08 |
| Date of Report | 2004-03-09 |
| Date of Event | 2004-03-05 |
| Date Mfgr Received | 2004-03-09 |
| Date Added to Maude | 2004-04-12 |
| 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 WEST CLARKE AVENUE P.O. BOX 359 |
| 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 | POGO ONE STEP DIAMOND MICRO POLISHER |
| Generic Name | DENTAL POLISHING INSTRUMENT |
| Product Code | EHJ |
| Date Received | 2004-04-08 |
| Model Number | NA |
| Catalog Number | 662010 |
| 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 | 508997 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE MILFORD DE 199630359 US |
| Baseline Brand Name | POGO ONE STEP DIAMOND MICRO-POLISHER REFILL PACKAGE |
| Baseline Generic Name | DENTAL POLISHING INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 662010 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-04-08 |