MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-03 for CRYOTIP 40709 manufactured by Irvine Scientific.
[20229891]
Irvine scientific received an medwatch form fda 3500a from the fda for a user facility that reported the event under report (b)(4). The event reported was that a cryopreservation loop failed ("exploded"), causing embryos to melt and therefore, lose viability.
Patient Sequence No: 1, Text Type: D, B5
[20421784]
The user facility did not report the event to irvine scientific. Irvine scientific was made aware of the event upon receipt of the medwatch form fda 3500a from the fda for the event. The medwatch form provided does not provide any additional information with regards to the device or the device lot number for an investigation to be performed. Details with regards to the product lot number have not been provided. The user facility did not report the event to irvine scientific and did not provide the product specific lot number within the user report, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022379-2012-00003 |
| MDR Report Key | 2858119 |
| Report Source | 06 |
| Date Received | 2012-12-03 |
| Date of Report | 2012-11-29 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2012-12-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2511 DAIMLER ST |
| Manufacturer City | SANTA ANA CA 927055588 |
| Manufacturer Country | US |
| Manufacturer Postal | 927055588 |
| Manufacturer Phone | 9492617800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOTIP |
| Generic Name | CRYOTIP |
| Product Code | MQH |
| Date Received | 2012-12-03 |
| Model Number | NA |
| Catalog Number | 40709 |
| Lot Number | NOT REPORTED |
| ID Number | NA |
| Operator | OTHER |
| 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 | 2012-12-03 |