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.
[145138333]
(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
[145138334]
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 had a spontaneous vaginal delivery. The patient had a blood loss of 700ml following delivery. Approximately 4 hours later, the patient required manual removal of the placenta, (the patient was given cefuroxime and metronidazole prophylactically for the procedure). At this time, the patient lost an additional 1000ml of blood (1700 ml total blood loss). To treat the post-partum hemorrhage, the patient was given ergometrine, syntocinon, and syntometrine with resolution. These events led to prolonged hospital stay. The patient was mildly anemic after the event and was given ferrous sulfate to take home. The provider (the principal investigator) reported that there is no causal relationship between the cook cervical ripening balloon and the manual removal of the placenta, post-partum hemorrhage or subsequent prolonged hospitalization. No additional consequences to the patient have been reported. Additional details regarding the patient and the event have been requested. At this time, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01043 |
| MDR Report Key | 8612660 |
| Report Source | FOREIGN,OTHER,STUDY,USER FACI |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-24 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2019-05-17 |
| 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 | 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 | 2019-05-15 |