MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-04 for ALCON TOTAL PLUS 25+ VITRECTOMY PACK * 8065751493 manufactured by Alcon Laboratories.
[2364583]
The nurse was completing the set-up of her case and noted that the handle of the light cord in the pack was loose. Therefore, she did not feel comfortable using it. She put it aside to later report and obtained new product to use to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2339736 |
| MDR Report Key | 2339736 |
| Date Received | 2011-11-04 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-10-19 |
| Report Date | 2011-11-04 |
| Date Reported to FDA | 2011-11-04 |
| Date Added to Maude | 2011-11-16 |
| 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 |
| 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 | ALCON TOTAL PLUS 25+ VITRECTOMY PACK |
| Generic Name | LIGHT HANDLE |
| Product Code | HQB |
| Date Received | 2011-11-04 |
| Model Number | * |
| Catalog Number | 8065751493 |
| Lot Number | 11019560X-2011-05 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES |
| Manufacturer Address | 9965 BUFFALO SPEEDWAY HOUSTON TX 77054 US 77054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-04 |