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 2018-09-11 for COOK? CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Inc.
[119811938]
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Per the instructions for use (ifu): the intended use indicates the cervical ripening balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. Contraindications include: transverse fetal orientation presenting part above the pelvic inlet. Precautions: if fetal membranes rupture spontaneously while this device is in place, it is recommended that both balloons be deflated and the device removed in preparation for spontaneous active labor contractions. 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
[119811939]
It was initially reported the patient gave birth with a right facial paralysis, with hematoma and temporal blood lump. A cervical ripening balloon involved for the intervention. Additional documentation was provided in french language and translated into english. The documents included are a physicians letter and a cerebral scan report. In the letter the physician reports, "i was required to see a patient, who gave birth at the (redacted) hospital, at 36 weeks + 6 days, with right facial palsy at birth, with hematoma and temporal sero-sanguine deformity. " "the only procedure performed was a balloon trigger. " details of cerebral scan: completed (b)(6) 2018. Date of birth: (b)(6) 2018. "indication: newborn, born at 36 weeks of amenorrhoea plus 6 days, birth weight (b)(6), whose delivery was triggered by cervical balloon, which was positioned high in the uterus, possibly traumatic. Finding of right facial palsy at birth with hematoma under the mastoid and the temporal sero- sanguine deformation. Inquiry into fracture of the petrous bone. " technique: device used: definition as 128, date of commissioning: (b)(6) 2015. Dosimetry: scan 19+2mgy. Cm head - neck. Ctdi vol: 15,05mgy without injections. Result: no detectable intra-cerebral lesion, especially no peri-cerebral collection. Ascertainment of a partial filling of the petro-mastoid cavities of the right petrous bone with respect to the left side, of the lateral area, sparing the greater part of the tympanic cavity. Doubt on a solution of continuity of the petrous bone at the level of the posterior part of the mastoid (at this level, the bone is thin). No other particular image to describe. Conclusion: confirmation of a trauma of the petrous bone. " request has been made for full event details, patient (maternal) pre-natal care and heath history, and the current status of the mother and infant. At the time of this report there is no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02623 |
| MDR Report Key | 7863988 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-09-11 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2018-09-11 |
| Model Number | NA |
| Catalog Number | J-CRB-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. Deathisabilit | 2018-09-11 |