MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-10-03 for OXANE HD manufactured by Pharmpur Gmbh.
[4930588]
It was reported that on (b)(6) 2014 the product was injected into the patient's eye for trauma-induced retinal detachment; on (b)(6) 2014 the product was observed to be adhering to the anterior chamber. A scraping procedure was performed but was not successful.
Patient Sequence No: 1, Text Type: D, B5
[12396103]
Investigation of this complaint is in progress. A supplemental reoprt will be submitted upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119279-2014-00242 |
| MDR Report Key | 4144014 |
| Report Source | 01 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-09-03 |
| Date of Event | 2014-07-30 |
| Date Mfgr Received | 2014-09-03 |
| Date Added to Maude | 2014-10-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON |
| Manufacturer Street | 50 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | PHARMPUR |
| Manufacturer Street | MESSERSCHMITTRING 33 |
| Manufacturer City | KRONIGSBRNN 86343 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 86343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXANE HD |
| Product Code | LWL |
| Date Received | 2014-10-03 |
| Lot Number | 12613 |
| 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 | 2014-10-03 |