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.
[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
Report Number | 1610287-2019-00004 |
MDR Report Key | 8331597 |
Report Source | LITERATURE |
Date Received | 2019-02-12 |
Date of Report | 2019-05-14 |
Date Mfgr Received | 2019-04-30 |
Date Added to Maude | 2019-02-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. CINDY MILAM |
Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
Manufacturer City | FORT WORTH TX 76134 |
Manufacturer Country | US |
Manufacturer Postal | 76134 |
Manufacturer Phone | 8176152231 |
Manufacturer G1 | AIR LIQUIDE |
Manufacturer Street | 13140 TI BLVD. |
Manufacturer City | DALLAS TX 75243 |
Manufacturer Country | US |
Manufacturer Postal Code | 75243 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ISPAN SULFUR HEXAFLUORIDE (SF6) GAS |
Generic Name | INTRAOCULAR GAS |
Product Code | LPO |
Date Received | 2019-02-12 |
Model Number | NA |
Catalog Number | 8065797001 |
Lot Number | ASKU |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AIR LIQUIDE |
Manufacturer Address | 13140 TI BLVD. DALLAS TX 75243 US 75243 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2019-02-12 |