MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for COOK CERVICAL RIPENING BALLOON J-CRBS-184000 G19981 manufactured by Cook Inc..
[142502422]
Hole was found to be present in the uterine balloon when filling with sterile water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085958 |
| MDR Report Key | 8527367 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-04-12 |
| Date Added to Maude | 2019-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | DILATOR, CERVICAL, HYGROSCOPIC - LAMINARIA |
| Product Code | HDY |
| Date Received | 2019-04-17 |
| Model Number | J-CRBS-184000 |
| Catalog Number | G19981 |
| Lot Number | 9502373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | DILATOR, CERVICAL, HYGROSCOPIC - LAMINARIA |
| Product Code | HDY |
| Date Received | 2019-04-17 |
| Model Number | J-CRBS-184000 |
| Catalog Number | G19981 |
| Lot Number | 9502373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |