MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-10-09 for INTRANPLUS IUP-C50 manufactured by Utah Medical Products.
[928108]
This (b)(6) pt was discharged post c-section on (b)(6) 2008. On (b)(6)2008, the pt had a piece of plastic come out of her vagina. It is the piece of plastic around the tip of the iupc. Per the md, there is no pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1195163 |
| MDR Report Key | 1195163 |
| Report Source | 99 |
| Date Received | 2008-10-09 |
| Date of Report | 2008-10-08 |
| Date of Event | 2008-09-19 |
| Date Facility Aware | 2008-09-24 |
| Report Date | 2008-10-08 |
| Date Reported to FDA | 2008-10-08 |
| Date Reported to Mfgr | 2008-10-08 |
| Date Added to Maude | 2010-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRANPLUS IUP-C50 |
| Generic Name | IUPC |
| Product Code | KXO |
| Date Received | 2008-10-09 |
| Lot Number | 1080817 |
| Device Expiration Date | 2013-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 S. 300 WEST MIDVALE UT 84647 US 84647 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-09 |