MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for COOK CERVICAL RIPENING BALLOON G19891 manufactured by Cook Medical.
[101025229]
A cervical balloon was placed with 80ml inserted into the vaginal side and 80ml inserted into the uterine side. Both rn and provider verified that 80ml's of fluid was inserted into each balloon at time of insertion. When balloon was removed 12 hrs after placement, 80ml's was removed from the uterine side, and only 28ml's was removed from the vaginal side. Both balloons were deflated with removal. Pt had no complaints of fluid leaking during time of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075496 |
| MDR Report Key | 7295845 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-21 |
| Date Added to Maude | 2018-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | CERVICAL BALLOON: RIPENING BALLOON |
| Product Code | HDY |
| Date Received | 2018-02-23 |
| Model Number | G19891 |
| Lot Number | 8294843 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN 47402 US 47402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-02-23 |