MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-03 for PENTAX M70151 manufactured by Pentax Of America, Inc..
| Report Number | 2518897-2019-00014 |
| MDR Report Key | 8760721 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-07-03 |
| Date of Report | 2019-06-09 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-06-09 |
| Date Added to Maude | 2019-07-03 |
| 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 07645 |
| Manufacturer Country | US |
| Manufacturer Postal | 07645 |
| Manufacturer Phone | 8004315880 |
| Manufacturer G1 | PENTAX OF AMERICA, INC. |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE NJ 07645 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07645 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | ENDOPROIQ SOFTWARE |
| Product Code | OUG |
| Date Received | 2019-07-03 |
| Model Number | M70151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 07645 US 07645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-03 |