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 |