ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-19 for ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797002 manufactured by Air Liquide.

Event Text Entries

[183725836] No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183725837] A nurse reported that an ophthalmic gas was used at 100% concentration during multiple pneumatic retinopexy surgeries after which the gas was confirmed to have lasted only one week in duration. There was no harm to any patient. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2020-00006
MDR Report Key9729773
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2020-01-21
Date Mfgr Received2020-02-04
Device Manufacturer Date2019-04-23
Date Added to Maude2020-02-19
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 FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
Manufacturer G1AIR LIQUIDE
Manufacturer Street13140 TI BLVD.
Manufacturer CityDALLAS TX 75243
Manufacturer CountryUS
Manufacturer Postal Code75243
Single Use3
Remedial ActionOT
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 Received2020-02-19
Model NumberNA
Catalog Number8065797002
Lot Number911311
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
10 2020-02-19

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