MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for SERVATOR H manufactured by S.a.l.f. Laboratorio Framacologico.
[145017886]
Product claims to have shell life of 18 months. Fda approval for 12 months. Product is very yellow in color. Temperature guidelines are not the same as predicate. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086577 |
| MDR Report Key | 8604843 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-08 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SERVATOR H |
| Generic Name | SET, PERFUSION, KIDNEY, DISPOSABLE |
| Product Code | KDL |
| Date Received | 2019-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S.A.L.F. LABORATORIO FRAMACOLOGICO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |