MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-12-26 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook, Inc..
[4555064]
The procedure was conducted on (b)(6) 2013. Double balloon both broken after placed for 3 hours. The complainant has confirmed that the balloon ruptured circumferentially. A section of the device did not remain inside the pt's body. The pt did not require any additional procedures due to this occurrence. According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[11716079]
(b)(4). Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00485 |
| MDR Report Key | 3754314 |
| Report Source | 08 |
| Date Received | 2013-12-26 |
| Date of Report | 2013-12-02 |
| Date of Event | 2013-11-27 |
| Date Facility Aware | 2013-11-27 |
| Report Date | 2013-12-02 |
| Date Mfgr Received | 2013-12-02 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-05-08 |
| 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 | RITA HARDEN, DIR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47402 |
| Manufacturer Country | US |
| Manufacturer Postal | 47402 |
| 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 | HDYU DILATOR, CERVICAL |
| Product Code | HDY |
| Date Received | 2013-12-26 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | U2356261 |
| ID Number | NA |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-26 |