MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-06 for INTRAN PLUS IUP-400 manufactured by Utah Med Products, Inc..
[114973]
Pt was 40+ weeks in active labor. Upon insertion of intran plus, there was a decrease in b/p into the 50's. There was a large amount of vaginal bleeding. An emergency c-section was performed with fetal demise.
Patient Sequence No: 1, Text Type: D, B5
[7831614]
Attempts by utah medical products, inc. , to obtain additional info and/or arrange on-site product evaluation have been unsuccessful.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718873-1996-00003 |
| MDR Report Key | 37345 |
| Report Source | 06 |
| Date Received | 1996-09-06 |
| Date of Event | 1996-08-01 |
| Date Mfgr Received | 1996-08-05 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1996-09-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAN PLUS |
| Generic Name | DISPOSABLE INTRAUTERINE PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 1996-09-06 |
| Model Number | IUP-400 |
| Catalog Number | IUP-400 |
| Lot Number | 61645-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37222 |
| Manufacturer | UTAH MED PRODUCTS, INC. |
| 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; 2. Other | 1996-09-06 |