MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-06 for CRYOTIP manufactured by Irvine Scientific.
[3641921]
Upon thaw for embryo transfer on (b)(6) 2013, the cryopreservation loop failed, "exploded," causing a loss to both embryos. The embryos were unable to be recovered and embryo transfer was canceled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031366 |
| MDR Report Key | 3281868 |
| Date Received | 2013-08-06 |
| Date of Report | 2013-08-01 |
| Date of Event | 2013-02-22 |
| Date Added to Maude | 2013-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2013-08-06 |
| Lot Number | 2062639 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | 2511 DAIMLER ST SANTA ANA CA 92705558 US 92705 5588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-06 |