MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-06 for INTRAUTERINE TRANSDUCER 2017AA00 manufactured by Corometrics Med System, Inc..
[18112]
The intra-uterine pressure catheter has proven unsatisfactory in its recording of baseline uterine tone. The baseline tone serves as a guiding tool during labor induction with oxytocin. Published standards for the safe administration of oxytocin include prohibition of its use if baseline uterine tone exceeds 20mm gh. Current catheter system routinely exhibits an unreliable baseline, sometimes suddenly recording at up to 50mm hg without any change in the pt's uterine tone. This unacceptable situation compromises pt care by interfering with oxytocin administration, & entails unacceptable medicolegal risk given the importance of thes erroneous readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000825 |
| MDR Report Key | 27049 |
| Date Received | 1995-10-06 |
| Date of Report | 1995-04-27 |
| Date Added to Maude | 1995-10-16 |
| 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 | INTRAUTERINE TRANSDUCER |
| Generic Name | TRANSDUCER |
| Product Code | HFN |
| Date Received | 1995-10-06 |
| Model Number | 2017AA00 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27844 |
| Manufacturer | COROMETRICS MED SYSTEM, INC. |
| Manufacturer Address | 61 BARNES PARK RD N WALLINGFORD CT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-10-06 |