MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-19 for CERVIDIL CERVICAL RIPENING FOR LABOR manufactured by Forest Laboratories.
[17431355]
Device inserted at 2130 1/3 for cervical ripening induction of labor on term pregnancy. Approx 3 hours later, pt got up to bathroom and device string came out but prostaglandin impregnated strip did not. Pt continued through very rapid, uncontrolled labor and delivery due to inability to remove device. Product was kept in freezer as required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008116 |
| MDR Report Key | 29378 |
| Date Received | 1996-01-19 |
| Date of Report | 1996-01-05 |
| Date of Event | 1996-01-04 |
| Date Added to Maude | 1996-01-23 |
| 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 | CERVIDIL CERVICAL RIPENING FOR LABOR |
| Generic Name | CERVICAL OPENING DEVICE |
| Product Code | MCR |
| Date Received | 1996-01-19 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30416 |
| Manufacturer | FOREST LABORATORIES |
| Manufacturer Address | NEW YORK NY 10022 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1996-01-19 |