MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-24 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological, Inc..
[1553281]
Physician had a resident staff member place the cervical ripening balloon for use in dilating a pt's unripened cervix. The device was removed from the pt within the 12 hour indwell time frame as indicated by ifu. Same physician was the attending physician and observed that the fetus had changed from a vertex head down presentation to the breach position well after the cervical ripening balloon was removed. A cesarean section was performed once breach position was determined. Physician feels that the cervical ripening balloon was the cause of the fetus moving into the breach position or becoming disengaged from the cervix. Further, physician felt that 80 cc's of fluid in each balloon was the primary concern for cause. Due to the breach position of the fetus a cesarean section was immediately performed.
Patient Sequence No: 1, Text Type: D, B5
[8633132]
Due to the complaint device not being returned and limited info received, noting several attempts have been made to talk with the physician to obtain additional info concerning the incident without success. Additional attempts to contact the physician will be made and should info become available it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2010-00019 |
| MDR Report Key | 1700904 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-24 |
| Date Mfgr Received | 2010-04-26 |
| Date Added to Maude | 2010-05-28 |
| 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 | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | HDY DILATOR, CERVICAL |
| Product Code | HDY |
| Date Received | 2010-05-24 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-05-24 |