MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-08-15 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[117574777]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[117574778]
User facility(uf) medwatch report (b)(4) was received 29jun2018. The uf report showed the facility reported, a cook cervical ripening balloon w/stylet was being placed when the stylet was felt through the tip, the device was removed from the patient. Additional information was received on 30jul2018 alleging, the metal stylet came out of cook catheter tip. No harm to the patient. Requests were made for additional information regarding; type of procedure being performed, if the procedure was able to completed, and patient outcome, however, the customer is not able to provide any further information. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02354 |
| MDR Report Key | 7784868 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-08-15 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2018-08-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-08-15 |
| Returned To Mfg | 2018-08-13 |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 8838141 |
| 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 | 2018-08-15 |