MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for COOK CERVICAL RIPENING BALLOON CATHTER J-CRBS-184000 G19891 manufactured by Cook, Inc..
[143450486]
The uterine balloon of the cook catheter ruptured after placement. Balloon was filled with 80 ml of fluid as per standard protocol. After inflating the balloon, a "swoosh" was heard on the fetal heart monitor and the patient felt immediate increase of pressure. Within a minute, patient began leaking pink tinged fluid, pad was placed under patient and patient continued to be monitored. The leaking continued. The provider was notified and instructed the nurse to check the fluid in the balloon. When the nurse pulled back the fluid from the uterine balloon into a syringe, she noticed dark red, bloody fluid. Nurse spoke to the provider and discontinued the balloon. The vaginal balloon was noted to be intact. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086190 |
| MDR Report Key | 8555181 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-20 |
| Date Added to Maude | 2019-04-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK CERVICAL RIPENING BALLOON CATHTER |
| Generic Name | DILATOR, CERVICAL, HYGROSCOPIC-LAMINARIA |
| Product Code | HDY |
| Date Received | 2019-04-25 |
| Model Number | J-CRBS-184000 |
| Catalog Number | G19891 |
| Lot Number | 9447223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |