MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for COOK CERVICAL RIPENING BALLOON G19891 J-CRBS-184000 manufactured by Cook Incorporated.
| Report Number | MW5087736 |
| MDR Report Key | 8754002 |
| Date Received | 2019-07-02 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-05-10 |
| Date Added to Maude | 2019-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR |
| Product Code | PFJ |
| Date Received | 2019-07-02 |
| Model Number | G19891 |
| Catalog Number | J-CRBS-184000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | BLOOMINGTON IN 46704 US 46704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-02 |