MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-02 for OXANE HD VRL700 manufactured by Pharmpur Gmbh.
[2054108]
The surgeon reports an unspecified issue during the extraction of oxane hd silicone oil, potentially associated with retina or capsule tissue. Additional info has been requested but has not been received
Patient Sequence No: 1, Text Type: D, B5
[9126768]
No sample was returned for eval. Investigation of this complaint is in progress. A supplemental report will be submitted upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119279-2011-00108 |
| MDR Report Key | 2118493 |
| Report Source | 01,05 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-05-04 |
| Date Mfgr Received | 2011-01-27 |
| Date Added to Maude | 2011-06-13 |
| 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 STE. 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | MESSERSCHMITTRING 33 |
| Manufacturer City | KONIGSBRUNN 86343 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 86343 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXANE HD |
| Generic Name | SILICONE OIL |
| Product Code | LWL |
| Date Received | 2011-06-02 |
| Model Number | VRL700 |
| Lot Number | 52009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMPUR GMBH |
| Manufacturer Address | KONIGSBRUNN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-02 |