MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-04 for MIRAGEL SPONGE MIRAGEL 9096 * manufactured by Mira, Inc..
[19077259]
Extruding scleral buckle and pain in right eye. On 7-8-98, removal of encircling element in right eye, miragel and hard silicone band.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015618 |
| MDR Report Key | 208910 |
| Date Received | 1999-02-04 |
| Date of Report | 1999-01-12 |
| Date of Event | 1998-07-08 |
| Date Added to Maude | 1999-02-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRAGEL SPONGE |
| Generic Name | SCLERAL BUCKLE COMPONENT FOR RETINAL DETACHMENT |
| Product Code | HQJ |
| Date Received | 1999-02-04 |
| Model Number | MIRAGEL 9096 |
| Catalog Number | * |
| Lot Number | H277 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 202745 |
| 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 | 909G |
| 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 | 1999-02-04 |