MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-21 for COOK'S CERVICAL RIPENING BALLOON REF J-CRBS-184000 G19891 manufactured by Cook Medical.
[4183040]
Cook's cervical ripening catheter inserted 2224 on (b)(6) 2014. Vaginal balloon inflated 60 ml with normal saline. Uterine balloon inflated 80 ml of normal saline per manufacturer guidelines. On (b)(6) 2014 at 0330, leakage noted from catheter, cervical balloon ruptured. Balloon sequester. Upon investigation noted leakage at blue tip. No apparent harm to pt. Dates of use: (b)(6) 2014. Diagnosis or reason for use: induction of labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034699 |
| MDR Report Key | 3647142 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-10 |
| Date of Event | 2014-02-07 |
| Date Added to Maude | 2014-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK'S CERVICAL RIPENING BALLOON |
| Generic Name | CERVICAL RIPENING BALLOON |
| Product Code | HDY |
| Date Received | 2014-02-21 |
| Model Number | REF J-CRBS-184000 |
| Catalog Number | G19891 |
| Lot Number | U2368885 |
| Device Expiration Date | 2016-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-21 |