MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-20 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological Inc..
[5423428]
A study site reported that a (b)(6) female primigravida underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2014. Crb was inserted on (b)(6) 2014 at 12:38 (vaginal balloon 60 ml of saline, uterine balloon 30 ml of saline). Insertion of crb was considered difficult. Crb was removed on (b)(6) 2014 at 17:25 due to complication of balloon: "balloon causing pain/pressure". Received epidural anesthesia on (b)(6) 2014 beginning at 17:48. Spontaneous vaginal delivery on (b)(6) 2014 at 01:38. Intrapartum chorioamnionitis symptoms began on (b)(6) 2014 (maternal fever greater than 100. 4 degrees f, sustained maternal tachycardia, fetal tachycardia, foul smelling amniotic fluid). The pt was treated with antibiotic therapy. This event was marked as "possibly" related to the crb and possibly related to the induction procedure. It was noted that the event did not lead to serious deterioration in health and the site responded that the device did not malfunction or deteriorate in characteristics or performance. The pt was discharged from hospital on 03/23/2014
Patient Sequence No: 1, Text Type: D, B5
[12866121]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2015-00052 |
| MDR Report Key | 4452574 |
| Report Source | 06 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-02 |
| Date of Event | 2014-03-21 |
| Date Facility Aware | 2014-03-21 |
| Report Date | 2015-01-02 |
| Date Mfgr Received | 2015-01-08 |
| Date Added to Maude | 2015-01-27 |
| 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 | LARRY POOL, MANAGER |
| 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 |
| Generic Name | DILATOR, CERVICAL |
| Product Code | HDY |
| Date Received | 2015-01-20 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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. Required No Informationntervention | 2015-01-20 |