MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for COOK MEDICAL REF J-CRBS-184000 REF G19891 manufactured by Cook Medical.
[98468071]
During induction of labor, a cook catheter cervical ripening balloon was utilized. After inserting the catheter and inflating the balloon, the balloon burst and the catheter could no longer be used. The patient continued with an uneventful labor and delivery of newborn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074891 |
| MDR Report Key | 7221572 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-19 |
| Date Added to Maude | 2018-01-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MEDICAL |
| Generic Name | COOK CERVICAL RIPENING BALLOON |
| Product Code | HDY |
| Date Received | 2018-01-25 |
| Model Number | REF J-CRBS-184000 |
| Catalog Number | REF G19891 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |