ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-22 for ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797005 manufactured by Air Liquide.

MAUDE Entry Details

Report Number1610287-2019-00021
MDR Report Key8812065
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-22
Date of Report2019-10-08
Date Mfgr Received2019-09-25
Device Manufacturer Date2018-06-08
Date Added to Maude2019-07-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1AIR LIQUIDE
Manufacturer Street13140 TI BLVD.
Manufacturer CityDALLAS TX 75243
Manufacturer CountryUS
Manufacturer Postal Code75243
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameISPAN SULFUR HEXAFLUORIDE (SF6) GAS
Generic NameINTRAOCULAR GAS
Product CodeLPO
Date Received2019-07-22
Model NumberNA
Catalog Number8065797005
Lot Number815907
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAIR LIQUIDE
Manufacturer Address13140 TI BLVD. DALLAS TX 75243 US 75243


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-22

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