MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for PENTAX ED-3490TK manufactured by Hoya Corporation Pentax Tokyo Office.
| Report Number | 9610877-2020-00047 |
| MDR Report Key | 9820498 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-11 |
| 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 GOELLER (TEMPORARY) |
| Manufacturer Street | 3 PARAGON DRIVE |
| Manufacturer City | MONTVALE, NJ |
| Manufacturer Country | US |
| Manufacturer Phone | 4315880231 |
| Manufacturer G1 | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Street | TSUTSUJIGAOKA 1-1-110 |
| Manufacturer City | AKISHIMA-SHI, 196-0012 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-0012 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NOT ISSUED YET |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENTAX |
| Generic Name | VIDEO DUODENOSCOPE |
| Product Code | FDT |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-09 |
| Model Number | ED-3490TK |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Manufacturer Address | TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI, 196-0012 JA 196-0012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |