MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-22 for STRATUS OCT PATIENT MODEL D 3000 manufactured by Carl Zeiss Meditec..
[967302]
Pt contacted the office 7 days after the use of the oct equipment on her, complaining of "burning in her eyes" and "blistering".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008724 |
| MDR Report Key | 1210867 |
| Date Received | 2008-10-22 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-08-20 |
| Date Added to Maude | 2008-11-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATUS OCT PATIENT MODEL D |
| Generic Name | OCT |
| Product Code | HLI |
| Date Received | 2008-10-22 |
| Model Number | 3000 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1263317 |
| Manufacturer | CARL ZEISS MEDITEC. |
| Manufacturer Address | DUBLIN CA 94568 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-22 |