MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-10-22 for POLISHER P0053-031 manufactured by Allemann.
[3910063]
A doctor's office reported that the polisher separated from the handpiece and hit her in they eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645240-2013-00002 |
| MDR Report Key | 3423049 |
| Report Source | * |
| Date Received | 2013-10-22 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-09-24 |
| Date Facility Aware | 2013-09-26 |
| Report Date | 2013-09-23 |
| Date Reported to FDA | 2013-09-23 |
| Date Reported to Mfgr | 2013-09-23 |
| Date Added to Maude | 2013-10-22 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLISHER |
| Generic Name | ORAL CAVITY ABRASIVE POLISHING AGENT |
| Product Code | EJR |
| Date Received | 2013-10-22 |
| Catalog Number | P0053-031 |
| Lot Number | 4933754 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEMANN |
| Manufacturer Address | INDUSTRIESTASSE 13 FL-9486 SCHAANWALD, LIECHTENSTEIN 9486 SZ 9486 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-22 |