MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-19 for COOK CERVICAL RIPENING BALLOON 18.0FR, 40 CM, 80 ML manufactured by Cook.
[4647547]
The proximal balloon on the cook cervical ripening balloon failed to deflate. Diagnosis or reason for use: pregnancy - for cervical ripening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036795 |
| MDR Report Key | 3893889 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-06-18 |
| Date of Event | 2014-06-17 |
| Date Added to Maude | 2014-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON 18.0FR, 40 CM, 80 ML |
| Generic Name | CERVICAL RIPENING BALLOON |
| Product Code | HDY |
| Date Received | 2014-06-19 |
| Lot Number | U2452709 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK |
| Manufacturer Address | BLOOMINGTON 47402 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-19 |