MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-13 for IPC-5000E manufactured by .
[2157930]
.
Patient Sequence No: 1, Text Type: D, B5
[9472533]
The pathology report on the placenta came back with evidence of "early, acute chorioamnionitis" and a "focal, mural hemorrhage adjacent to the umbilical vein near the insertion site at the placenta," clinical significance of such was listed as "unk. " based upon discussions with hosp personnel, it appears as if the iupc was not placed in accordance with the instructions for use. It is not clear whether or not the iupc perforated the umbilical cord, but that possibility cannot be ruled out at this time, however that is a known risk factor of any iupc.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722684-2011-00002 |
| MDR Report Key | 2253519 |
| Report Source | 99 |
| Date Received | 2011-09-13 |
| Date Mfgr Received | 2011-08-15 |
| Date Added to Maude | 2011-09-20 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRIAN MCROBERTS, DIR |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | HFN |
| Date Received | 2011-09-13 |
| Model Number | IPC-5000E |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-13 |