MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-17 for OCU-FILM H1302306712 REF 230671 manufactured by Medtronic Ophthalmics: A Division Of Medtronic Xomed, Inc..
[412747]
Ocu-film is a transparent, elastic cover for ophthalmic pen lights. When the 2 boxes were opened, the covers were brittle and deteriorated with yellow spots throughout.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 633959 |
| MDR Report Key | 633959 |
| Date Received | 2005-08-17 |
| Date of Report | 2005-08-17 |
| Date of Event | 2005-08-01 |
| Report Date | 2005-08-17 |
| Date Reported to FDA | 2005-08-17 |
| Date Added to Maude | 2005-09-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCU-FILM |
| Generic Name | OPHTHALMIC LIGHT COVER |
| Product Code | KYT |
| Date Received | 2005-08-17 |
| Model Number | H1302306712 |
| Catalog Number | REF 230671 |
| Lot Number | 32310500 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 623528 |
| Manufacturer | MEDTRONIC OPHTHALMICS: A DIVISION OF MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-17 |