MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-08 for CRYOTIP UNK manufactured by Irvine Scientific.
[17882126]
Cryopreservation loop failed ("exploded"), causing embryos to melt and lose viability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2814310 |
| MDR Report Key | 2814310 |
| Date Received | 2012-10-08 |
| Date of Report | 2012-10-08 |
| Date of Event | 2012-06-04 |
| Report Date | 2012-10-08 |
| Date Reported to FDA | 2012-10-08 |
| Date Added to Maude | 2012-11-01 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | MICROTOOL, ASSISTED REPRODUCTION |
| Product Code | MQH |
| Date Received | 2012-10-08 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE SCIENTIFIC |
| Manufacturer Address | 2511 DAIMLER STREET SANTA ANA CA 92705558 US 92705 5588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-08 |