MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-28 for COOK CERVICAL RIPENING BALLOON WITH STYLET J-CRBS-184000 manufactured by Cook Urological Inc.
[4276802]
While attempting to place the balloon in a multiparous female who was an inductions of labor for intrauterine growth restriction (iugr) led to a significant cervical hemorrhage. After inflating the uterine balloon with the initial amount, prior to inflating the vaginal balloon, there was a large gush of blood from the vagina. The fetal heart tracing remained intact and the pts cervix was notably more effaced and dilated. Pt continued to hemorrhage, the cervix was inspected and there were abrasions noted at 3:00 and 9:00. Ring forceps were applied, the pt was monitored, and when the ring forceps were removed, the bleeding had abated. The pt lost approximately 1500cc of blood but had a successful nsvd.
Patient Sequence No: 1, Text Type: D, B5
[11822712]
Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00140 |
| MDR Report Key | 3736027 |
| Report Source | 07 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-07 |
| Report Date | 2014-03-07 |
| Date Mfgr Received | 2014-03-11 |
| Date Added to Maude | 2014-04-10 |
| 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 | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON WITH STYLET |
| Generic Name | HDY DILATOR, CERVICAL |
| Product Code | HDY |
| Date Received | 2014-03-28 |
| Model Number | NA |
| Catalog Number | J-CRBS-184000 |
| Lot Number | UNK |
| ID Number | NA |
| 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 UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-28 |