MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-19 for * IUP-400 manufactured by Utah Medical.
[17769598]
Pt admitted to labor and delivery on 12/9/1997 for induction of labor. Indication: post dates 41 weeks gestation. Routine admission orders were followed. The external fetal monitors were placed and heart rate was 130-140 baseline with numerous accelerations. Spontaneous rupture of membranes at 1005 a. M. Physician applied a fetal scalp electrode at 1012 a. M. , fht 140-150 with variability present. The iupc, intran plus was placed at 1013 a. M. By the physician. At 1014 a. M. Fht deceleration down to 90's was noted and did not respond to position changes, o2 administration, or increased i. V. Fluid. At 1018 fht decleration continued down to 40's-60's. The pt was prepared for an emgergency c-section and taken to the operating room at 1021 a. M. A flaccid, blood covered infant was delivered. There was a copious amount of blood from the airway. The resuscitation efforts were unsuccessful. The pathology report indicated a slight laceration in the middle of the placenta. The proximal end of the umbilical cord appeared ragged and torn. The surgeon recorded that the cord broke when attempting to deliver the placenta. The report also stated diffuse recent intra-alveolar hemorrhage of right and left lungs. Medical device involvement was not confirmed until autopsy report was completed 01-15-98. This accounts for delay in reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 144347 |
| MDR Report Key | 144347 |
| Date Received | 1998-01-19 |
| Date of Report | 1998-01-19 |
| Date of Event | 1997-12-09 |
| Date Facility Aware | 1998-01-15 |
| Report Date | 1998-01-19 |
| Date Reported to FDA | 1998-01-19 |
| Date Reported to Mfgr | 1998-01-19 |
| Date Added to Maude | 1998-01-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | INTRAUTERINE-PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 1998-01-19 |
| Model Number | IUP-400 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140760 |
| Manufacturer | UTAH MEDICAL |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Baseline Brand Name | INTRAN PLUS |
| Baseline Generic Name | IUPC |
| Baseline Model No | IUP-400 |
| Baseline Catalog No | IUP-400 |
| Baseline ID | NA |
| Baseline Device Family | INTRAN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955443 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1998-01-19 |