MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-08-22 for SHIMADZU 503-79460-41 manufactured by Shimadzu Corporation.
| Report Number | 8030233-2019-00001 |
| MDR Report Key | 8924010 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-08-22 |
| Date of Report | 2019-07-07 |
| Date of Event | 2019-04-28 |
| Date Facility Aware | 2019-06-08 |
| Report Date | 2019-06-08 |
| Date Reported to Mfgr | 2019-06-08 |
| Date Mfgr Received | 2019-06-08 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2019-08-22 |
| 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. TOSHIO KADOWAKI |
| Manufacturer Street | 1, NISHINOKYO, KUWABARA-CHO NAKAGYO-KU |
| Manufacturer City | KYOTO, KYOTO 604-8511 |
| Manufacturer Country | JA |
| Manufacturer Postal | 604-8511 |
| Manufacturer G1 | SHIMADZU CORPORATION |
| Manufacturer Street | 1, NISHINOKYO, KUWABARA-CHO NAKAGYO-KU |
| Manufacturer City | KYOTO, 604-8511 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 604-8511 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIMADZU |
| Generic Name | RADSPEED PRO |
| Product Code | KPR |
| Date Received | 2019-08-22 |
| Model Number | 503-79460-41 |
| Device Expiration Date | 2017-01-24 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIMADZU CORPORATION |
| Manufacturer Address | 1, NISHINOKYO-KUWABARACHO NAKAGYO-KU KYOTO CITY, 604-8511 JA 604-8511 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-22 |