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 2019-05-08 for COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000 manufactured by Cook Inc.
[144421968]
(b)(6). Occupation: other healthcare professional - study coordinator. 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
[144421969]
It is reported during a study of methods of labor induction, the patient was randomized to induction at (b)(6) gestation using a cook cervical ripening balloon w/stylet for advanced maternal age ((b)(6)). After delivery, the patient experienced a post partum hemorrhage of 1500ml. The patient required manual removal of the placenta, and experienced an additional 600ml of blood loss (2100ml total). This issue led to a prolonged hospital stay. The patient was transfused with 2 units of blood. She was reported to be anemic at discharge and was sent home with ferrous sulfate. The provider (chief investigator) reported that there is no causal relationship between the cook cervical ripening balloon w/stylet and the post-partum hemorrhage experienced by the patient. No additional consequences to the patient have been reported as occurring. Additional details regarding the patient and event have been requested. At this time, no information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01040 |
| MDR Report Key | 8591016 |
| Report Source | FOREIGN,OTHER,STUDY,USER FACI |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-24 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2019-05-23 |
| Device Manufacturer Date | 2017-10-19 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-05-08 |
| Model Number | G19891 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 8306637 |
| 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. Hospitalization; 2. Other | 2019-05-08 |