MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-19 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[136495633]
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[136495634]
It was reported, the baby changed from head-first presentation to breech position after using the j-crbs. They were able to rotate the baby back to head-first presentation and the woman delivered vaginally. Additional details were provided. The fetal station at time of device insertion was determined by inner palpation and reported as above the pelvic inlet. The cook cervical ripening balloon w/stylet was placed before amniotomy with bishop score 4. The balloons were inflated to 80 + 80 ml with saline. The device was in place for 13 hours and no rupture of membranes occurred during placement. No induction medications were given to the patient. When the catheter was removed, the baby had rotated to breech presentation. Attempts to rotate the baby back to head-first presentation were successful. The induction was continued with angusta (misoprostol per os) and the baby delivered vaginally. In the doctor? S opinion there is nothing wrong with the device itself. The reason for the event is rather that the catheter shall not be used when the presenting part is too high or when the baby is in a non-stabilized position. Then the balloon mechanically can rotate the baby. No harm to the patient or baby has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00484 |
| MDR Report Key | 8350272 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-19 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2019-02-19 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-19 |