MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-05-06 for OXANE 5700 VRL600 manufactured by Pharmpur Gmbh.
[2023780]
It was reported that while the surgeon was performing a pars plana vitrectomy due to retinal detachment, dekaline (dk-line - perfluorodecalin - c10f18) had been filled in and afterwards silicone oil tamponade was injected. During the filling with the dekaline and the oxane 5700 silicone oil, a sticky texture built up and the retina became firm. The oxane 5700 silicone oil was removed and retina was detached. According to the reporter, after the surgeon filled the same dekaline again, the retina re-attached. A new injector with silicone oil was used. This time there was no unwanted reaction. The surgeon assumes that the oxane 5700 was polluted/particulated.
Patient Sequence No: 1, Text Type: D, B5
[9109021]
The device was returned for analysis and the evaluation is underway. Per the directions for use, if perfluorocarbons after intraoperative use are exchanged for silicone oil, it is very likely that last perfluorocarbon droplets will remain in the eye with a considerable risk of creating an additional problem for the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119279-2011-00097 |
| MDR Report Key | 2088055 |
| Report Source | 01,05 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-04-06 |
| Date Mfgr Received | 2011-04-06 |
| Date Added to Maude | 2011-05-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON TRELFORD, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE SUITE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 10574 ACACIA SUITE D-1 |
| Manufacturer City | RANCHO CUCAMONGA CA 91730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXANE 5700 |
| Generic Name | SILICONE OIL |
| Product Code | LWL |
| Date Received | 2011-05-06 |
| Returned To Mfg | 2011-04-15 |
| Model Number | VRL600 |
| Lot Number | 34809 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMPUR GMBH |
| Manufacturer Address | KONIGSBRUNN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-06 |