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.
[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
| Report Number | 2518435-2019-00001 |
| MDR Report Key | 8511384 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2019-04-12 |
| 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 | STEVE MILLER |
| Manufacturer Street | 12800 WEST LITTLE YORK ROAD |
| Manufacturer City | HOUSTON TX 77041 |
| Manufacturer Country | US |
| Manufacturer Postal | 77041 |
| Manufacturer Phone | 7138962280 |
| Manufacturer G1 | AIRGAS USA |
| Manufacturer Street | 6141 EASTON ROAD |
| Manufacturer City | PLUMSTEADVILLE PA 189490310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 189490310 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SULFUR HEXAFLUORIDE |
| Generic Name | SULFUR HEXAFLUORIDE |
| Product Code | LPO |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2018-02-27 |
| Catalog Number | TR9088 |
| Lot Number | 722125 |
| Device Expiration Date | 2019-07-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRGAS USA |
| Manufacturer Address | 6141 EASTON ROAD PLUMSTEADVILLE PA 189490310 US 189490310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-12 |