MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-25 for SURGILENS manufactured by Chiron Corp..
[26834]
During surgery the circulating nurse was asked to give tobradex on the corneal shield. At this time the scrub tech noticed irregular edges on the shield. After a closer look rptr noticed a large portion missing from the edge. The surgeon rejected the lens and another one was opened and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009375 |
| MDR Report Key | 33722 |
| Date Received | 1996-06-25 |
| Date of Report | 1996-06-13 |
| Date of Event | 1996-06-12 |
| Date Added to Maude | 1996-06-28 |
| 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 | PHARMACIST |
| 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 | SURGILENS |
| Generic Name | CORNEAL SHIELD |
| Product Code | MOE |
| Date Received | 1996-06-25 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | Q2Q796A |
| ID Number | NA |
| Device Expiration Date | 1998-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 35073 |
| Manufacturer | CHIRON CORP. |
| Manufacturer Address | NA NA CLAREMONT CA 91711 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-06-25 |