MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-30 for OPMI DRAPE 326071 manufactured by Carl Zeiss, Inc..
[10071]
The lens, which is part of the drape, was scratched.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004198 |
| MDR Report Key | 18042 |
| Date Received | 1994-11-30 |
| Date of Report | 1994-11-29 |
| Date Added to Maude | 1994-12-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI DRAPE |
| Generic Name | MICROSCOPE DRAPE |
| Product Code | HMW |
| Date Received | 1994-11-30 |
| Catalog Number | 326071 |
| Lot Number | 2486 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17970 |
| Manufacturer | CARL ZEISS, INC. |
| Manufacturer Address | THORNWOOD NY 10594 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-11-30 |