MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-27 for SPS-1 manufactured by Organ Recovery Systems, Inc..
[63285395]
Patient Sequence No: 1, Text Type: N, H10
[63285396]
Patient was identified as someone affected by the potentially contaminated organ preservation solution. No harm has been noted at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6204785 |
| MDR Report Key | 6204785 |
| Date Received | 2016-12-27 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-21 |
| Report Date | 2016-12-22 |
| Date Reported to FDA | 2016-12-22 |
| Date Reported to Mfgr | 2016-12-22 |
| Date Added to Maude | 2016-12-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | SPS-1 |
| Generic Name | ORGAN PRESERVATION FLUID |
| Product Code | KDL |
| Date Received | 2016-12-27 |
| Lot Number | PBR0060392 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC. |
| Manufacturer Address | 1 PIERCE PL. STE. 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-27 |