MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-02-05 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[134998514]
(b)(6). Occupation: other healthcare professional. (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
[134998515]
It is reported that in an unblinded study evaluating methods of labor induction, the patient had a cook cervical ripening balloon placed to induce labor. After an unstated time interval, the patient required an operative vaginal delivery with a kiwi vacuum, and experienced a post partum hemorrhage with a total blood volume loss of 1. 2 liters. The patient was given tranexamic acid, syntocinon, and syntometrine to treat the post partum hemorrhage with resolution. The patients hemoglobin level was 106. 0 g/l (10. 6 g/dl) the next day. It is reported that these events led to a prolonged hospital stay. The physician stated that there is no causal relationship between the adverse events and the cook cervical ripening balloon. Additional details have been requested about the patient and the event. No additional information has been provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00207 |
| MDR Report Key | 8304893 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-05 |
| 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 | 2019-02-05 |
| 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. Hospitalization; 2. Other | 2019-02-05 |