MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-03-15 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[102577296]
Concomitant medical products: oxytocin was used after the device was removed from the patient. (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
[102577297]
It was reported that a cook cervical ripening balloon w/stylet was inserted on (b)(6) 2018 at 11:20 am. On (b)(6) 2018 at 2:50pm, the ripening balloon was removed and labor induction was started with oxytocics. A complicated uterine rupture then happened affecting the right anterolateral and posterolateral walls of the uterus and a hemorrhage started, leading to an emergency c-section (b)(6) at 1:15am. It was reported,? Balloon discarded. Red code: repair of lesions, stop the bleeding, patient in reanimation?. Requests were made for additional information regarding the outcome of the mom and baby, oxytoxin protocol being used, obstetric and gynecological history of the patient prior to this pregnancy and birth, complications of this pregnancy, if the patient received any medications from the time the device was inserted until it was removed, and the providers opinions regarding the reason for the spontaneous rupture; however, the information has not been provided. Per the instructions for use (ifu)? The device is not intended to be in place for longer than 12 hours. Time the placement of the device 12 hours prior to the planned induction?. Under warnings it states? The product should not be left indwelling for longer than 12 hours?. Under the potential adverse events listed in the ifu, uterine rupture is listed as a risk associated with the device and labor induction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00463 |
| MDR Report Key | 7343087 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-03-15 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-04-11 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-03-15 |
| 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 |
| 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 | 2018-03-15 |
| Catalog Number | J-CRBS-184000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2018-03-15 |