MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-01-08 for COOK? CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Inc.
[96633003]
(b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[96633004]
It was reported during a labor induction procedure, a cook? Cervical ripening balloon was used on the patient. The physician used a speculum to gain cervical access and then cleaned the patient's cervix with cleaning solution to prepare for device insertion. The physician inserted the cervix and both balloons entered the cervical canal. The physician inflated the uterine balloon with 40 ml of normal saline and the device was pulled back against the internal cervical os. The vaginal balloon was then inflated with 20 ml of saline. The physician added more fluid to each balloon in turn, in 20 ml increments until the uterine balloon and vaginal balloon contained 80 ml of saline. The physician later removed the device from the patient. The patient had a postoperative fever after and was at a temperature of 37. 2?. By active treatment symptom relief, the patient was returned to normal condition. The patient has since recovered and was discharged from the hospital. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. No adverse effects or consequences were reported to the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00015 |
| MDR Report Key | 7172118 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2018-01-08 |
| Date of Report | 2018-04-12 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2017-06-14 |
| Date Added to Maude | 2018-01-08 |
| 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 |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2018-01-08 |
| Catalog Number | J-CRB-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 | 2018-01-08 |