MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for VIASPAN (BELZER UW) COLD STORAGE SOLUTION manufactured by Fresenius Kabi Austria.
[45601588]
Patient Sequence No: 1, Text Type: N, H10
[45601589]
Spontaneous non-serious. ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003708554-2016-00005 |
| MDR Report Key | 5667180 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-19 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-19 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES YOUNG |
| Manufacturer Street | 425 PRIVET ROAD |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2152937263 |
| Manufacturer G1 | FRESENIUS KABI AUSTRIA |
| Manufacturer Street | HAFNERSTRASSE 36 |
| Manufacturer City | GRAZ, AUSTRIA 8055 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 8055 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIASPAN (BELZER UW) COLD STORAGE SOLUTION |
| Generic Name | VIASPAN (BELZER UW - CSS), PRODUCT CODE: KDL |
| Product Code | KDL |
| Date Received | 2016-05-19 |
| Returned To Mfg | 2016-04-26 |
| Lot Number | 16II2120 |
| Device Expiration Date | 2016-09-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS KABI AUSTRIA |
| Manufacturer Address | HAFNERSTRASSE 36 GRAZ, AUSTRIA 8055 AU 8055 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |