IRVINE SCIENTIFIC VITRIFICATION KIT 90133

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2022379-2013-00002
MDR Report Key3434873
Report Source06
Date Received2013-10-15
Date of Report2013-10-15
Date of Event2013-04-08
Date Mfgr Received2013-10-15
Date Added to Maude2013-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1830 EAST WARNER AVE.
Manufacturer CitySANTA ANA CA 927055505
Manufacturer CountryUS
Manufacturer Postal927055505
Manufacturer Phone9492617800
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIRVINE SCIENTIFIC VITRIFICATION KIT
Generic NameVITRIFICATION KIT
Product CodeMQL
Date Received2013-10-15
Model NumberNA
Catalog Number90133
Lot Number90133050120301
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIRVINE SCIENTIFIC
Manufacturer AddressSANTA ANA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-10-15

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