MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-22 for SCLERAL BUCKLE X 2 * 240 287 manufactured by Mira Inc.
[15681476]
Patient had vitrectomy with scleral buckle; required explant due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 766481 |
| MDR Report Key | 766481 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-09-22 |
| Date of Event | 2006-05-15 |
| Report Date | 2006-09-22 |
| Date Reported to FDA | 2006-09-22 |
| Date Added to Maude | 2006-10-04 |
| 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 | SCLERAL BUCKLE X 2 |
| Generic Name | SCLERAL BUCKLE |
| Product Code | HQJ |
| Date Received | 2006-09-22 |
| Model Number | * |
| Catalog Number | 240 287 |
| Lot Number | Y144 Y145 |
| ID Number | * |
| Device Availability | N |
| Device Age | 70 DY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 754366 |
| Manufacturer | MIRA INC |
| Manufacturer Address | 414 QUAKER HWY UXBRIDGE MA 015691644 US |
| Baseline Brand Name | SCLERAL BUCKLE X 2 |
| Baseline Generic Name | SCLERAL BUCKLE |
| Baseline Model No | * |
| Baseline Catalog No | 240 287 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2006-09-22 |