ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-02-12 for ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797001 manufactured by Air Liquide.

Event Text Entries

[135888239] No sample or lot number information 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. Additional information has been requested. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[135888240] In a literature report, a physician reported that ophthalmic gas was instilled into a patient's left eye at an intended 20% concentration mixed with filtered room air during a pars plana vitrectomy surgery in order to treat a macular hole. Post operatively, the patient experienced elevated intraocular pressure, nausea, vomiting and severe eye pain which required two consecutive eye taps and a subsequent vitrectomy procedure for full gas with oil exchange and reformation of the anterior chamber. Three weeks postoperatively, the patient's left eye had no perception to light with massive, ischemic destruction of the intraocular tissues. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2019-00004
MDR Report Key8331597
Report SourceLITERATURE
Date Received2019-02-12
Date of Report2019-05-14
Date Mfgr Received2019-04-30
Date Added to Maude2019-02-12
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 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 Received2019-02-12
Model NumberNA
Catalog Number8065797001
Lot NumberASKU
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. Deathisabilit 2019-02-12

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