MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,study,user faci report with the FDA on 2019-05-15 for COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000 manufactured by Cook Inc.
[145218241]
(b)(6). Occupation: other healthcare professional-study coordinator. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[145218242]
It is reported during a study of labor induction methods, the patient was randomized to induction using a cook cervical ripening balloon w/stylet. The patient required a forcep assisted vaginal delivery. After delivery, the patient lost 1. 3l of blood. The patient received syntocinon, and tranexamic acid to treat post-partum hemorrhage with resolution. These events (forceps assisted vaginal delivery and post-partum hemorrhage) led to prolonged hospitalization. Due to the blood loss, the patient was anemic and was sent home with iron tablets. The provider (principal investigator) reported there is no causal relationship between the cook cervical ripening balloon and the need for forcep assisted delivery, post-partum hemorrhage or subsequent prolonged hospitalization. No additional consequences to the patient have been reported. Additional details regarding the patient and the even have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01045 |
| MDR Report Key | 8613285 |
| Report Source | FOREIGN,OTHER,STUDY,USER FACI |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-24 |
| Date of Event | 2018-09-09 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2017-10-19 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| Model Number | G19891 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 8306637 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization; 2. Other | 2019-05-15 |