MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for ISPAN SULFUR HEXAFLUORIDE (SF6) GAS 8065797005 manufactured by Air Liquide.
[144256261]
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
[144256262]
A nurse reported that a bubble of ophthalmic gas was instilled into a patient's eye during a vitrectomy with scleral buckle surgery. The gas bubble did not last as long as expected. Patient impact information is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2019-00011 |
| MDR Report Key | 8577553 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-07-23 |
| Date Mfgr Received | 2019-07-08 |
| Date Added to Maude | 2019-05-03 |
| 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 | 0 |
| Brand Name | ISPAN SULFUR HEXAFLUORIDE (SF6) GAS |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2019-05-03 |
| Model Number | NA |
| Catalog Number | 8065797005 |
| 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 | 2019-05-03 |