SULFUR HEXAFLUORIDE TR9088

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-12 for SULFUR HEXAFLUORIDE TR9088 manufactured by Airgas Usa.

Event Text Entries

[141912207] Event: customer reported to distributor that they had been using a gas cylinder of sulfur hexafluoride since (b)(6) 2017 with no issues but two recent cases involving retina re-attachment had re-detached. No further information was provided not were additional reports provided that patients eventually had successful reattachment or not. No individual patient information is known such as age, sex, etc.. On 2/27/2018, the distributor reported the case to manufacturer. The actual date of the patient events is unknown other than that they occurred on the same day. The product was returned to manufacturer. Manufacturer conducted a review of the batch product record and discovered no issues. Manufacturer also re-analyzed the cylinder of gas and the product met the original specification.
Patient Sequence No: 1, Text Type: N, H10


[141912209] Event: case 1 of 2. Customer reported to distributor that they had been using a gas cylinder of sulfur hexafluoride since (b)(6) 2017 with no issues but two recent cases involving retina re-attachment had re-detached. No further information was provided nor were additional reports provided that patients eventually had successful reattachment or not. No individual patient information is known such as age, sex, etc.. On 2/27/2018, the distributor reported the case. The actual date of the patient events is unknown other than that they occurred on the same day. The product was returned to manufacturer. Manufacturer conducted a review of the batch product record and discovered no issues. Manufacturer also re-analyzed the cylinder of gas and the product met the original specification.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518435-2019-00001
MDR Report Key8511384
Report SourceDISTRIBUTOR
Date Received2019-04-12
Date of Report2019-04-11
Date of Event2018-01-01
Date Mfgr Received2018-02-27
Date Added to Maude2019-04-12
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 ContactSTEVE MILLER
Manufacturer Street12800 WEST LITTLE YORK ROAD
Manufacturer CityHOUSTON TX 77041
Manufacturer CountryUS
Manufacturer Postal77041
Manufacturer Phone7138962280
Manufacturer G1AIRGAS USA
Manufacturer Street6141 EASTON ROAD
Manufacturer CityPLUMSTEADVILLE PA 189490310
Manufacturer CountryUS
Manufacturer Postal Code189490310
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSULFUR HEXAFLUORIDE
Generic NameSULFUR HEXAFLUORIDE
Product CodeLPO
Date Received2019-04-12
Returned To Mfg2018-02-27
Catalog NumberTR9088
Lot Number722125
Device Expiration Date2019-07-31
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAIRGAS USA
Manufacturer Address6141 EASTON ROAD PLUMSTEADVILLE PA 189490310 US 189490310


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-12

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