MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-12 for INTRAN PLUS IUP IUP-400 UNK manufactured by Utah Medical Products.
[48812]
Iupc inserted by physician without difficulty, according to procedure. Following insertion pt complained of pain in lower right quadrant. Fetal heart rate dropped to 50-60 bpm. Decision for c/s made. Baby boy delivered with apgars of 6 & 8. Upon inspection of the uterus after delivery the physician noted a small puncture on posterior wall of uterus approx 1cm in diameter. Mother and baby had a normal post-partum course and were discharged on the third post-op day in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011201 |
| MDR Report Key | 86387 |
| Date Received | 1997-04-24 |
| Date of Report | 1997-04-16 |
| Date of Event | 1997-04-11 |
| Date Added to Maude | 1997-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAN PLUS IUP |
| Generic Name | INTRAUTERINE PRESSURE CATHETER SYSTEM |
| Product Code | HGS |
| Date Received | 1997-12-12 |
| Model Number | IUP-400 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | CTU 63362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85578 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-04-24 |