MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for COOK G19891 J-CRBS-184000 manufactured by Cook Incorporated.
[119038194]
The catheter balloon (uterine) ruptured during filling. The patient felt a 'weird feeling' around 30-40cc. The 60cc sterile saline was pushed. Then the catheter slide out with an empty balloon. A new one was used without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7841662 |
| MDR Report Key | 7841662 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-07-02 |
| Report Date | 2018-08-09 |
| Date Reported to FDA | 2018-08-09 |
| Date Reported to Mfgr | 2018-09-04 |
| Date Added to Maude | 2018-09-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | COOK |
| Generic Name | CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR |
| Product Code | PFJ |
| Date Received | 2018-09-04 |
| Model Number | G19891 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 8781892 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-04 |