MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for PENTAX 9310HD manufactured by Pentax Of America, Inc..
| Report Number | 2518897-2020-00037 |
| MDR Report Key | 9864698 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-01-21 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-03-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM (TEMPORARY) |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 4315880231 |
| Manufacturer G1 | PENTAX OF AMERICA, INC. |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE, NJ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | HD - DIGITAL VIDEO CAPTURE |
| Product Code | OUG |
| Date Received | 2020-03-23 |
| Model Number | 9310HD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTAX OF AMERICA, INC. |
| Manufacturer Address | 3 PARAGON DRIVE MONTVALE, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |