MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-07 for PHILIPS ZOOM ZM2665 manufactured by Discus Dental, Llc.
| Report Number | 1000582314-2019-00002 |
| MDR Report Key | 8679709 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-07 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-05-11 |
| Date Mfgr Received | 2019-05-13 |
| Device Manufacturer Date | 2015-06-19 |
| Date Added to Maude | 2019-06-07 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRANCES ESTRADA |
| Manufacturer Street | 1700A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703542 |
| Manufacturer G1 | DISCUS DENTAL, LLC |
| Manufacturer Street | 1700 A SOUTH BAKER AVE |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91761 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS ZOOM |
| Generic Name | ZOOM CHAIRSIDE KIT |
| Product Code | EEG |
| Date Received | 2019-06-07 |
| Model Number | ZM2665 |
| Lot Number | 15225011 |
| Device Expiration Date | 2016-09-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | 1700A SOUTH BAKER AVE. ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-07 |