MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-15 for CRYOTIP 40709 manufactured by Irvine Scientific.
[3937829]
Irvine scientific received a maude event report (foi) from the fda for a user facility that reported the event under voluntary report number: mw5031305. The event reported was that upon the thaw for embryo transfer, the cryopreservation loop failed causing a loss of embryos. The embryos were unable to be recovered and the embryo transfer was canceled.
Patient Sequence No: 1, Text Type: D, B5
[11252960]
The user facility did not report the event to irvine scientific. Irvine scientific was only made aware of the event upon the receipt of the maude event report (foi) from the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2013-00001 |
| MDR Report Key | 3456651 |
| Report Source | 06 |
| Date Received | 2013-10-15 |
| Date of Report | 2013-10-15 |
| Date of Event | 2013-04-08 |
| Date Mfgr Received | 2013-10-15 |
| Date Added to Maude | 2013-12-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1830 EAST WARNER AVE |
| Manufacturer City | SANTA ANA CA 927055505 |
| Manufacturer Country | US |
| Manufacturer Postal | 927055505 |
| Manufacturer Phone | 9492617800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2013-10-15 |
| Model Number | NA |
| Catalog Number | 40709 |
| Lot Number | 40709IST-056A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-15 |