MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-08 for MIRAGEL 908G manufactured by Mira Inc..
[15482716]
Md reporting that pt was complaining of double vision and discomfort. A re-operation disclosed that the implant had fragmented and was removed. Original implantation was 1990, due to ocular trauma to right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2000-00004 |
| MDR Report Key | 293604 |
| Report Source | 05 |
| Date Received | 2000-08-08 |
| Date of Report | 2000-08-08 |
| Date of Event | 2000-07-06 |
| Date Mfgr Received | 2000-07-25 |
| Date Added to Maude | 2000-09-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Street | 87 RUMFORD AVE |
| Manufacturer City | WALTHAM MA 02454 |
| Manufacturer Country | US |
| Manufacturer Postal | 02454 |
| Manufacturer Phone | 7818942200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRAGEL |
| Generic Name | SCLERAL BUCKLING COMPONENT |
| Product Code | HQJ |
| Date Received | 2000-08-08 |
| Model Number | 908G |
| Catalog Number | 908G |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 284201 |
| Manufacturer | MIRA INC. |
| Manufacturer Address | 87 RUMFORD AVE. WALTHAM MA 02454 US |
| Baseline Brand Name | MIRAGEL |
| Baseline Generic Name | SCLERAL BUCKLING IMPLANT |
| Baseline Model No | 908G |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | SCLERAL BUCKLING COMPONENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K821793 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-08-08 |