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 2018-05-11 for GUARDIA? ACCESS EMBRYO TRANSFER CATHETER K-JETS-7019 manufactured by Cook Inc.
[108007152]
(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
[108007153]
It was reported that the user said that under a microscope, a foreign matter was found inside the inner guardia? Access embryo transfer catheter. 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 | 1820334-2018-01314 |
| MDR Report Key | 7507241 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-11 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-06 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2017-12-08 |
| Date Added to Maude | 2018-05-11 |
| 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 | 2018-05-11 |
| 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 | 2018-05-11 |