MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-08 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.
[107655504]
(b)(4). 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
[107655505]
It was reported that the user opened the package, checked the integrity of the device, and found out there is oily substance like matter inside the tube. There were no adverse consequences to the patient as a result of this reported issue. The device did not make contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01276 |
| MDR Report Key | 7495426 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-08 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-05-08 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUARDIA? ACCESS EMBRYO TRANSFER CATHETER |
| Generic Name | MQF CATHETER, ASSISTED REPRODUCTION |
| Product Code | MQF |
| Date Received | 2018-05-08 |
| Catalog Number | K-JETS-7019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-05-08 |