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 IRVINE SCIENTIFIC VITRIFICATION KIT 90133 manufactured by Irvine Scientific.
[3951098]
Irvine scientific received a maude event report (foi) from the fda for a user facility that reported the event under the voluntary report no. Mw5031305. The event reported 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
[11394791]
The lot number provided in the report, 90133050120301, does not correspond with a lot number that irvine scientific manufactured for this product. However, from the nomenclature of the lot number which includes the catalog #, year, month and lot number produced, we determined that they were referring to 90133-dso120301, which is a lot number for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2013-00002 |
| MDR Report Key | 3434873 |
| 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 | 2013-11-29 |
| 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 | IRVINE SCIENTIFIC VITRIFICATION KIT |
| Generic Name | VITRIFICATION KIT |
| Product Code | MQL |
| Date Received | 2013-10-15 |
| Model Number | NA |
| Catalog Number | 90133 |
| Lot Number | 90133050120301 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |