MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-31 for LABTICIAN OPHTHALMIA INC. 11917 * manufactured by Labtician Ophthalmic Inc..
[329445]
Pt scheduled for removal of scleral buckle left eye. Eye had become infected and buckle had extended. Removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 541320 |
| MDR Report Key | 541320 |
| Date Received | 2004-08-31 |
| Date of Report | 2004-08-24 |
| Date of Event | 2003-09-10 |
| Date Facility Aware | 2003-09-10 |
| Report Date | 2004-08-24 |
| Date Added to Maude | 2004-09-01 |
| 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 | 3 |
| 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 | LABTICIAN OPHTHALMIA INC. |
| Generic Name | SCLERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2004-08-31 |
| Model Number | 11917 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | STYLE #276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 530656 |
| Manufacturer | LABTICIAN OPHTHALMIC INC. |
| Manufacturer Address | 2140 WINSTON PARK DR UNIT 6 OAKVILLE ONTARIO CA L6H 5V5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-08-31 |