MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-10 for DIACOMP FEATHER LITE 5024424U0 manufactured by Eve Ernst Vetter Gmbh.
[59714921]
Investigation results: no product was returned for evaluation. It appears to be unintended user error. This is an isolated occurrence.
Patient Sequence No: 1, Text Type: N, H10
[59714922]
From e-mail. After placing a simple resin tooth #19, the doctor started polishing the resin using a fldc5m feather lite intra-oral composite polisher - green. Upon polishing, the disc engaged the floor of the mouth and proceeded to wrap itself around the tissue. Doctor claims that there was nothing the he could do to stop the incident until the momentum of the handpiece discontinued. Only then was the doctor able to unravel the tissue from the disc. A laceration was left behind approximately 1. 3cm by 7mm. The doctor referred the patient to an oral surgeon for repair. The doctor noted on oct/21/2016 that the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032227-2016-00011 |
| MDR Report Key | 6094395 |
| Date Received | 2016-11-10 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-10-17 |
| Date Facility Aware | 2016-10-17 |
| Report Date | 2016-11-10 |
| Date Reported to FDA | 2016-11-10 |
| Date Reported to Mfgr | 2016-11-10 |
| Date Added to Maude | 2016-11-10 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIACOMP FEATHER LITE |
| Generic Name | DENTAL POLISHER |
| Product Code | EJQ |
| Date Received | 2016-11-10 |
| Catalog Number | 5024424U0 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EVE ERNST VETTER GMBH |
| Manufacturer Address | RASTATTER STR. 30, PFORZHEIM 75179 GM 75179 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-10 |