MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for SILIKON 1000 OIL 8065601185 manufactured by Primapharm, Inc..
[63186364]
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
[63186365]
A patient reported that ophthalmic oil was used in an unspecified procedure. The oil was later removed from her eye however, some oil was retained. After three months, the retained oil emulsified which made it hard for the patient to see. Additional information has been requested, but is not expected to be received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2016-00131 |
| MDR Report Key | 6201043 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2016-12-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | PRIMAPHARM, INC. |
| Manufacturer Street | 3443 TRIPP COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SILIKON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2016-12-22 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRIMAPHARM, INC. |
| Manufacturer Address | 3443 TRIPP COURT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-22 |