MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-04-30 for ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE ES 5000 S manufactured by Bausch & Lomb, Inc..
[22229339]
Investigation of this event is in progress. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22243216]
It was reported that a patient developed cystoid macular edema after having a vitrectomy due to a retinal detachment on (b)(6) 2014. No other information available. Additional information has been requested, but no additional information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2015-01168 |
| MDR Report Key | 4749057 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-03-31 |
| Date Mfgr Received | 2015-03-31 |
| Date Added to Maude | 2015-05-06 |
| 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 SPENCER |
| 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 | KONIGSBRUNN 86343 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 86343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE |
| Generic Name | SILICONE OIL |
| Product Code | LWL |
| Date Received | 2015-04-30 |
| Model Number | ES 5000 S |
| Lot Number | 30914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-30 |