MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-15 for ENDO ILLUMINATOR * 110-20 manufactured by Infinitech, Inc..
[33123]
During vitrectomy surgery of left eye two (2) pieces of metal shavings were visible within eye. Magnet utilized to remove metal. No harm to pt expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010272 |
| MDR Report Key | 50004 |
| Date Received | 1996-11-15 |
| Date of Report | 1996-11-01 |
| Date of Event | 1996-10-29 |
| Date Added to Maude | 1996-11-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | ENDO ILLUMINATOR |
| Generic Name | ENDO ILLUMINATOR 20G |
| Product Code | HJM |
| Date Received | 1996-11-15 |
| Model Number | * |
| Catalog Number | 110-20 |
| Lot Number | 614106 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 50731 |
| Manufacturer | INFINITECH, INC. |
| Manufacturer Address | 750 GODDARD AVE CHESTERFIELD MO 63005 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-15 |