MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-31 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[134595995]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[134595996]
It was reported there is a hole in the balloon. Water leaked out immediately. The stylet came though and poked through balloon. This occurred with two cook cervical ripening balloon w/stylets from the same lot on the same day. No adverse consequences have been reported. Additional details regarding the patient and the event have been requested. No further information has been forthcoming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00205 |
| MDR Report Key | 8292618 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-31 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-03-02 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2019-01-31 |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2019-01-31 |
| Returned To Mfg | 2019-01-29 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 8783332 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-31 |