MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-12 for LIGHT PIPE 5026098X-2005-10 * manufactured by Alcon Laboratories,inc..
[20508894]
The light fiber was loose and could be pulled apart. It was removed off the field and sent to biomed for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 679443 |
| MDR Report Key | 679443 |
| Date Received | 2006-01-12 |
| Date of Report | 2006-01-12 |
| Date of Event | 2005-11-28 |
| Report Date | 2006-01-12 |
| Date Reported to FDA | 2006-01-12 |
| Date Added to Maude | 2006-03-01 |
| 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 | LIGHT PIPE |
| Generic Name | SURGICAL LIGHT |
| Product Code | FCT |
| Date Received | 2006-01-12 |
| Model Number | 5026098X-2005-10 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 668711 |
| Manufacturer | ALCON LABORATORIES,INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY; MAIL STOP FORTH WORTH TX 76134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-12 |